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Chembio DPP HIV 1/2 Assay

FDA UDI

Class II (US FDA UDI)

by Chembio Diagnostic Systems

Identity

Trade Name
Chembio DPP HIV 1/2 Assay FDA UDI
Generic Name
HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
Device Name
The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice. FDA UDI
Model / Reference
65-9500-0 FDA UDI
Description
The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice. FDA UDI

Identifiers

Primary DI / UDI-DI
00607158000007 FDA UDI
FDA Product Code
MZF FDA UDI
GMDN Term
HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3956 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Chembio DPP HIV 1/2 Assay by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test.

Cleared under the same submission

BP120032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chembio Diagnostic Systems

Sources (1)

  • FDA UDI cab0775b-bf7a-4bec-a1e4-eec58eec5b02 34 fields · synced Jun 1, 2026