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HIV-1/2 Antibody Test Controls

FDA UDI

Class II (US FDA UDI)

by MedMira Laboratories Inc

Identity

Trade Name
HIV-1/2 Antibody Test Controls FDA UDI
Generic Name
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical FDA UDI
Device Name
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met. FDA UDI
Model / Reference
815311007521 FDA UDI
Description
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met. FDA UDI

Identifiers

Primary DI / UDI-DI
10628451188251 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

HIV-1/2 Antibody Test Controls 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 5b379fb8-aef8-4327-9a97-93e4b7233720 35 fields · synced May 30, 2026