Chapter 3822 — Customs Tariff Headings

BinaxNOW Malaria Test Kit

> The BinaxNOW Malaria Test Kit is a rapid in-vitro diagnostic device that uses monoclonal antibodies to detect Plasmodium falciparum HRP-2 and aldolase in whole blood. It is presented on a nitrocellulose membrane backing and is specifically designed for malaria diagnosis, qualifying as a prepared diagnostic reagent under tariff item 3822.11.00.

ICT Malaria Pf Test Device

> The ICT Malaria Pf Test Device is an immunochromatographic test that detects HRP-2 antigen on a backing strip for visual diagnosis of Plasmodium falciparum. As a prepared diagnostic reagent specifically for malaria, it is classified under tariff item 3822.11.00.

Malaria HRP-2 Detection Microplate Kit

> The Malaria HRP-2 Detection Microplate Kit is an ELISA-based assay with HRP-2 capture antibodies coated on microplate wells, used for quantitative detection of malaria parasites. It is a prepared laboratory reagent specifically for malaria, fitting tariff item 3822.11.00.

Malaria Pf/Pv/Pan Antigen Combo Test Cassette

> The Malaria Pf/Pv/Pan Antigen Combo Test Cassette is a rapid immunochromatographic test that detects HRP-2, pLDH, and pan-pLDH for multiple Plasmodium species. It is a prepared diagnostic reagent kit on a backing, specifically for malaria, and falls under tariff item 3822.11.00.

Malaria Rapid Diagnostic Test Kit (RDT) - CareStart

> The CareStart Malaria RDT Kit is a lateral flow immunoassay designed to detect Plasmodium falciparum HRP-2 and lactate dehydrogenase (pLDH) in blood samples. It is a prepared diagnostic reagent kit on a backing, specifically for malaria, and thus falls under tariff item 3822.11.00.

ParaSight F Malaria Test Strips

> ParaSight F Malaria Test Strips use monoclonal antibodies to detect Plasmodium falciparum HRP-2 on a plastic backing for visual detection in blood samples. As a prepared diagnostic reagent specifically for malaria, it is classified under tariff item 3822.11.00.

SD Bioline Malaria Ag P.f/P.v Test Kit

> The SD Bioline Malaria Ag P.f/P.v Test Kit is a lateral flow test that detects HRP-2 and pLDH for Plasmodium falciparum and Plasmodium vivax on a nitrocellulose backing. It is a prepared diagnostic reagent kit specifically for malaria, qualifying under tariff item 3822.11.00.

Aedes Dengue NS1 Antigen Rapid Test Kit

A rapid lateral flow immunoassay kit designed to detect Dengue virus NS1 antigen in human blood samples. Because Dengue is transmitted by Aedes mosquitoes, this diagnostic reagent falls squarely under tariff item 3822.12.00, which covers reagents for Zika and other Aedes-borne diseases.

Aedes-Transmitted Virus Multiplex Serology Kit

A multiplex bead-based assay kit for serologic detection of antibodies to Zika, Dengue, and Chikungunya viruses, all transmitted by Aedes mosquitoes. This prepared diagnostic reagent is designed for simultaneous detection of multiple Aedes-borne diseases, making it classifiable under tariff item 3822.12.00.

Chikungunya Virus IgG/IgM Combo Test Strip

Immunochromatographic test strips on a plastic backing for simultaneous detection of IgG and IgM antibodies to Chikungunya virus, which is transmitted by Aedes albopictus and Aedes aegypti mosquitoes. These prepared diagnostic reagents are specifically designed for an Aedes-borne disease, qualifying for tariff item 3822.12.00.

Dengue Fever IgM Capture ELISA Reagent Kit

An ELISA kit containing coated plates and liquid reagents for IgM capture detection of Dengue virus serotypes 1-4, all transmitted by Aedes aegypti mosquitoes. This prepared diagnostic reagent is tailored for Aedes-borne diseases, making it classifiable under tariff item 3822.12.00.

Rapid Zika NS1 Antigen Test Cassette

A point-of-care test cassette detecting Zika NS1 antigen in serum, with a nitrocellulose backing and complete with buffer and reagents. Since Zika is transmitted by Aedes mosquitoes, this prepared diagnostic reagent falls under tariff item 3822.12.00.

Zika Microcephaly Risk Diagnostic Panel

A comprehensive reagent panel for Zika virus detection, including PCR and serology components, designed to assess microcephaly risks associated with Aedes-transmitted Zika. This prepared diagnostic reagent is specifically for an Aedes-borne disease, qualifying for tariff item 3822.12.00.

Zika Virus IgM ELISA Kit

An ELISA kit for detecting IgM antibodies against the Zika virus in human serum or plasma samples. As a prepared laboratory reagent for an Aedes-borne disease, it is classifiable under tariff item 3822.12.00.

Zika Virus RNA PCR Detection Kit

A real-time RT-PCR reagent kit for qualitative detection of Zika virus RNA in clinical samples such as serum or urine. This prepared laboratory reagent is specifically for an Aedes-borne disease, making it classifiable under tariff item 3822.12.00.

Abbott Alinity ABO/Rh Slide Test Reagents

>- These dried reagent cards contain monoclonal anti-A, anti-B, anti-AB, and anti-D antibodies for automated slide agglutination blood grouping on Alinity s systems. They are prepared diagnostic reagents on a backing, specifically designed for determining blood groups, and therefore fall under tariff item 3822.13.00.

Bio-Rad IH-Gel Cards Anti-D

>- These gel column cards contain anti-D reagent in microtube columns for automated blood grouping and antibody screening via gel centrifugation technology. They are prepared diagnostic reagents on a backing, used specifically for blood-grouping, and are classified under tariff item 3822.13.00.

Grifols DG Gel Neutral Cards for Blood Typing

>- These neutral gel cards are used with separate blood grouping antisera for antibody screening and crossmatching after ABO/Rh typing. When supplied with blood grouping reagents on a gel matrix backing, they are prepared diagnostic reagents for blood-grouping and fall under tariff item 3822.13.00.

Immucor Capture-R Ready Screen Blood Grouping Kit

>- These reagent cards use solid-phase anti-IgG for blood grouping and crossmatch testing with Capture-R technology. They are prepared reagents on a backing designed specifically for blood group antibody detection, so they are classified under tariff item 3822.13.00.

Ortho BioVue ABO Blood Grouping Cards

>- These plastic cards are coated with dried anti-A, anti-B, and anti-D reagents for rapid slide agglutination testing to determine ABO and Rh blood groups. They are prepared diagnostic reagents on a backing, specifically for blood-grouping, and are classified under tariff item 3822.13.00.

Ortho Clinical Diagnostics Anti-A,B Blood Grouping Reagent Cards

>- These blended monoclonal anti-A,B reagent cards are used for confirming blood group O and detecting subgroups. They are prepared diagnostic reagents on a plastic backing specifically for blood-grouping applications, falling under tariff item 3822.13.00.

Siemens Atellica ABO Forward Typing Cards

>- These automated reagent cards are for forward typing in the Atellica STRAT system for high-throughput ABO blood grouping. They are prepared diagnostic reagents on a backing, designed for blood-grouping, and fall under tariff item 3822.13.00.

Adenovirus Antigen Immunoassay Kit

DFA (direct fluorescent antibody) reagents containing adenovirus hexon antigens and type-specific monoclonal antibodies, applied to specimen slides for respiratory diagnosis. These are prepared diagnostic reagents, not excluded by Chapter 38 notes, and fall under heading 38.22.

Antibiotic Susceptibility Test Panels

Frozen microdilution panels containing dried antibiotics at MIC concentrations for bacterial susceptibility testing. These are prepared laboratory reagents in 96-well plate format used in clinical microbiology laboratories, classifiable under tariff item 3822.19.00.

Antisera Preservation Solution with Carbon Tetrachloride

A liquid diagnostic reagent containing polyclonal antisera stabilized with carbon tetrachloride, used in immunological precipitation tests for veterinary and human tuberculosis diagnostics. This product is a prepared diagnostic reagent, not put up in measured doses or for retail sale, and does not contain separate chemically defined compounds in a form excluded by Chapter 38 notes.

Blood Typing Antisera Kit

Monoclonal antisera kit containing Anti-A, Anti-B, and Anti-D reagents for forward blood grouping on slide or microplate. These are prepared diagnostic reagents used in transfusion laboratories for blood typing, falling under tariff item 3822.19.00 as 'Other' diagnostic or laboratory reagents.

Cancer Biomarker Multiplex Kit

Luminescent bead-based multiplex assay for 10 key cancer biomarkers (PSA, CA125, CEA, etc.) in serum. Contains capture beads, detection antibodies and standards as prepared laboratory diagnostic reagents under tariff item 3822.19.00.

Carbon Tetrachloride Antibody Detection Strip

Prepared laboratory test strips on a backing with immobilized antibodies and carbon tetrachloride preservative for detecting autoimmune disorders in hospital pathology labs. These strips are diagnostic reagents on a backing, classifiable under heading 38.22 as they are not excluded by Chapter 38 notes.

Carbon Tetrachloride Extraction Solvent Kit for Pesticide Residue Analysis

A diagnostic reagent kit containing carbon tetrachloride for extracting pesticides from food samples in environmental testing laboratories. It is used in multi-residue analysis methods for food safety monitoring. Although it contains a chemical solvent, it is put up as a prepared laboratory reagent for diagnostic purposes, falling under this tariff item.

Carbon Tetrachloride Fat Extraction Reagent for Dairy Analysis

A Soxhlet extraction reagent containing carbon tetrachloride for determining fat content in milk and dairy products per AOAC official methods. It is a prepared laboratory reagent for food safety diagnostics. Although the solvent is a chemical, its presentation as a diagnostic reagent kit places it under this tariff item.

Carbon Tetrachloride Lyme Disease ELISA Kit

A complete ELISA kit for Borrelia burgdorferi antibody detection using carbon tetrachloride stabilized antigens and conjugates, used for Lyme disease diagnosis in clinical laboratories. This kit is a prepared diagnostic reagent put up as a kit, falling under heading 38.22 as it is not excluded by Chapter 38 notes.

Cell Culture Contamination Detection Kit

PCR-based detection kit for common cell culture contaminants including mycoplasma, bacteria and fungi species. Contains extraction reagents, master mix and species-specific primers on disc backing under tariff item 3822.19.00.

Clostridium difficile Toxin A/B Antigen Kit

Lateral flow immunoassay containing C. difficile toxin A and B antigens with detection antibodies on membrane backing, used for rapid laboratory diagnosis of antibiotic-associated diarrhea. This product is a prepared diagnostic reagent on a backing, classifiable under heading 38.22 as it is not excluded by Chapter 38 notes.

COVID-19 IgG/IgM Rapid Test Cassette

Lateral flow immunoassay cassette for detecting SARS-CoV-2 IgG and IgM antibodies in human serum, plasma or whole blood. This prepared diagnostic reagent on a backing qualifies under tariff item 3822.19.00 as a laboratory test kit.

Cryptosporidium/Giardia Antigen Combo Test

Monoclonal antibody-based lateral flow test detecting Cryptosporidium parvum and Giardia lamblia antigens in stool, prepared on nitrocellulose membrane backing for parasitology labs. This product is a prepared diagnostic reagent on a backing, falling under heading 38.22 as it is not excluded by Chapter 38 notes.

DNA Damage Comet Assay Kit

Complete kit for single cell gel electrophoresis containing lysis buffer, alkaline buffer, staining reagents and slides. These are prepared laboratory reagents for genotoxicity testing in toxicology research, falling under tariff item 3822.19.00.

ELISA Antigen Test Kit with Methyl Chloroform

A diagnostic reagent kit for enzyme-linked immunosorbent assay (ELISA) containing specific antigens and methyl chloroform (1,1,1-trichloroethane) as a solvent stabilizer, used in clinical labs to detect viral infections. This product is a prepared diagnostic reagent, not excluded by Chapter 38 notes, and falls under heading 38.22.

ELISA Test Kit for Human Insulin

A complete enzyme-linked immunosorbent assay (ELISA) kit designed for the quantitative detection of human insulin in serum or plasma samples. This prepared diagnostic reagent kit falls under tariff item 3822.19.00 as it contains coated microplates and detection reagents.

Enzyme Activity Assay Kit (LDH)

Colorimetric assay kit measuring LDH enzyme activity in cell lysates and serum samples at 492 nm. Contains substrate, dye and standards as prepared diagnostic reagents under tariff item 3822.19.00 for cell biology and clinical research.

Food Allergen Detection Lateral Flow Kit

Rapid lateral flow strips with antibodies for detecting gluten residues in food products at 20 ppm sensitivity. These are prepared diagnostic reagents on nitrocellulose backing for food safety laboratory testing, falling under tariff item 3822.19.00.

Group B Streptococcus Antigen Test

Latex agglutination kit detecting Group B Strep capsular polysaccharide antigens from vaginal/rectal swabs, used for maternal screening for neonatal infection prevention. This product is a prepared diagnostic reagent, not excluded by Chapter 38 notes, and falls under heading 38.22.

Hepatitis B Surface Antigen ELISA

Microplate-based ELISA reagents containing HBsAg and monoclonal detection antibodies for hepatitis B screening, used in clinical laboratories as prepared diagnostic reagents on plastic backing. This product falls under heading 38.22 as it is not excluded by Chapter 38 notes.

HIV p24 Antigen/Antibody Combo Kit

Fourth-generation HIV diagnostic reagent containing recombinant p24 antigens and anti-HIV antibodies on solid phase backing, detecting both antigen and antibodies for early infection diagnosis. This product is a prepared diagnostic reagent on a backing, classifiable under heading 38.22 as it is not excluded by Chapter 38 notes.

Hormone Panel ELISA Kit (TSH/T4/T3)

Three-in-one ELISA kit measuring TSH, Free T4 and T3 hormones simultaneously for thyroid function screening. Contains coated microplates, conjugates, substrates and standards as prepared diagnostic reagents under tariff item 3822.19.00.

H. pylori Urease Antigen Test

Rapid urease test reagents containing Helicobacter pylori urease antigens with detection antibodies on test strip backing, used for gastric biopsy diagnosis of peptic ulcer disease. This product is a prepared diagnostic reagent on a backing, falling under heading 38.22 as it is not excluded by Chapter 38 notes.

Influenza A/B Antigen Test Strip

Lateral flow test strips containing influenza A and B viral antigens with detection antibodies on nitrocellulose backing, used for rapid diagnosis of respiratory infections. This product is a prepared diagnostic reagent on a backing, classifiable under heading 38.22 as it is not excluded by Chapter 38 notes.

Legionella Urinary Antigen Test

An immunochromatographic test strip device for detecting Legionella pneumophila serogroup 1 antigen in urine samples. It consists of monoclonal antibodies fixed on a membrane backing and is used for rapid diagnosis of Legionnaires' disease. This is a prepared diagnostic reagent on a backing, not a medicament, so it falls under tariff item 3822.19.00.

Luminex Multiplex Bead-Based Assay Kit

Magnetic microsphere-based assay kit containing color-coded beads conjugated with capture antibodies for simultaneous detection of multiple cytokines in biological samples. Classified under tariff item 3822.19.00 as prepared laboratory reagents.

Methyl Chloroform Allergy Test Panel

A diagnostic panel with multiple allergen antigens preserved in methyl chloroform for skin prick testing and in vitro RAST assays, used by allergists for identifying IgE-mediated hypersensitivity. This product is a prepared diagnostic reagent, classifiable under heading 38.22 as it is not excluded by Chapter 38 notes.

Methyl Chloroform Calibration Standard for GC-MS

A certified reference material containing a known concentration of methyl chloroform for calibrating gas chromatography-mass spectrometry (GC-MS) instruments in environmental laboratories. It is used for volatile organic compound (VOC) analysis compliance testing. As a certified reference material, it is classified under heading 38.22, specifically this tariff item.

Methyl Chloroform Rheumatoid Factor Test Cards

Latex agglutination test cards with rheumatoid factor antigens preserved using methyl chloroform for rapid rheumatoid arthritis screening in physician offices and clinics. These cards are prepared diagnostic reagents on a backing, falling under heading 38.22 as they are not excluded by Chapter 38 notes.

Methyl Chloroform Viral Antigen Microplate

96-well microplates coated with viral antigens preserved in methyl chloroform solution for high-throughput ELISA screening in research labs, essential for COVID-19 serology and influenza diagnostics. These microplates are prepared diagnostic reagents on a backing, classifiable under heading 38.22 as they are not excluded by Chapter 38 notes.

Norovirus Antigen Detection Kit

An enzyme immunoassay (EIA) kit for detecting norovirus genogroup I/II antigens in stool samples. The kit includes microplate wells coated with capture antibodies and detection antibodies, constituting a prepared diagnostic reagent on a backing. It is used for laboratory diagnosis of viral gastroenteritis outbreaks and is not a medicament.

Protein Purification Column Kit

Affinity chromatography spin columns pre-packed with Ni-NTA resin for His-tagged protein purification. Contains binding/wash/elution buffers as prepared laboratory reagents under tariff item 3822.19.00 for molecular biology research.

qPCR Viral RNA Detection Master Mix

Ready-to-use quantitative PCR master mix containing primers, probes, enzymes and buffers optimized for SARS-CoV-2 RNA detection. This prepared laboratory reagent qualifies under tariff item 3822.19.00 for molecular diagnostic applications.

Rotavirus Antigen ELISA Kit

An enzyme-linked immunosorbent assay (ELISA) kit for quantitative detection of rotavirus VP6 antigens in stool samples. The kit includes microplate strips pre-coated with antibodies and detection reagents, functioning as a prepared diagnostic reagent on a backing. It is intended for laboratory diagnosis of rotavirus infections.

RSV Fusion Protein Antigen Test

A monoclonal antibody-based capture test for detecting Respiratory Syncytial Virus (RSV) fusion protein antigens in nasal wash specimens. The test uses a membrane backing with immobilized antibodies and is a prepared diagnostic reagent for pediatric respiratory infections. It is not a medicament and is classified as a diagnostic laboratory reagent.

SARS-CoV-2 Antigen Detection Kit

A rapid diagnostic reagent kit for detecting SARS-CoV-2 spike protein antigens in nasal swab samples. The kit includes test strips with monoclonal antibodies on a membrane backing, designed for point-of-care COVID-19 diagnosis. It is a prepared diagnostic reagent on a backing, not a medicament, and falls under this tariff item.

Streptococcus Antigen Latex Kit

A latex agglutination reagent kit for detecting group A Streptococcus antigens from throat swabs. The kit contains antibody-coated latex particles that react with bacterial antigens on test cards, serving as a prepared diagnostic reagent. It is used for rapid laboratory identification of streptococcal infections.