← Back to catalogue

Chembio SURE CHECK HIV 1/2 Assay

FDA UDI

Class II (US FDA UDI)

by Chembio Diagnostic Systems

Identity

Trade Name
Chembio SURE CHECK 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 SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® 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 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice. FDA UDI
Model / Reference
60-9507-0 FDA UDI
Description
The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® 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 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice. FDA UDI

Identifiers

Primary DI / UDI-DI
00607158000069 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

No

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 SURE CHECK 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

BP050009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Chembio Diagnostic Systems

Sources (1)

  • FDA UDI 607a3ed4-8208-48a5-bd87-7ea8581a7467 34 fields · synced May 30, 2026