Gs

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name: GS FDA UDI
Generic Name: HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Device Name: GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL FDA UDI
Model / Reference: 26223 FDA UDI
Description: GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL FDA UDI

Identifiers

Catalog Number: 26223 FDA UDI
Primary DI / UDI-DI: 00847865010672 FDA UDI
FDA Product Code: MZF FDA UDI
GMDN Term: HIV1/HIV2 antigen/antibody IVD, control 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1.5 Milliliter FDA UDI

Category: HIV1/HIV2 antigen/antibody IVD, control

Gs by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as HIV1/HIV2 antigen/antibody IVD, control.

PreciControl HIV Gen II — Roche Diagnostics Corp. · Class I
PreciControl HIV; HIV-2 + GrpO — Roche Diagnostics Corp. · Class I
LIAISON XL MUREX Control HIV Ab/Ag HT — Diasorin S.P.A
PreciControl Release HIV Gen II — Roche Diagnostics Corp. · U
Alinity — Abbott
Alinity — Abbott
ACCESS HIV Ag/Ab combo QC — Beckman Coulter, Inc. · Class I
ADVIA Centaur® CHIV QC — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

BP100064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bio-Rad Laboratories

Sources (1)

FDA UDI c41b1895-6e93-4066-9a8e-4b295f1143da 38 fields · synced May 30, 2026