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Reveal G4 Rapid HIV-1/2 Antibody Test

FDA UDI

Class II (US FDA UDI)

by MedMira Laboratories Inc

Identity

Trade Name
Reveal G4 Rapid HIV-1/2 Antibody Test FDA UDI
Generic Name
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms. FDA UDI
Model / Reference
815311007583 FDA UDI
Description
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms. FDA UDI

Identifiers

Primary DI / UDI-DI
00628451188179 FDA UDI
FDA Product Code
MZF FDA UDI
GMDN Term
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

Reveal G4 Rapid HIV-1/2 Antibody Test by MedMira Laboratories Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical.

Cleared under the same submission

BK231015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MedMira Laboratories Inc

Sources (1)

  • FDA UDI c9e2095c-f048-4db6-bf29-3da95eeab8de 34 fields · synced Jun 1, 2026