← Back to catalogue

Universal Buffer

FDA UDI

Class II (US FDA UDI)

by MedMira Laboratories Inc

Identity

Trade Name
Universal Buffer 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 rapid tests are available, this test should be used in appropriate multi-test algorithms. FDA UDI
Model / Reference
815311007606 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 rapid tests are available, this test should be used in appropriate multi-test algorithms. FDA UDI

Identifiers

Primary DI / UDI-DI
00628451188094 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Universal Buffer 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.

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
MedMira Laboratories Inc

Sources (1)

  • FDA UDI 91174673-86e8-4b5a-807d-b826476ced62 35 fields · synced Jun 6, 2026