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Geenius

FDA UDI

Class U (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Geenius FDA UDI
Generic Name
HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Geenius HIV 1/2 Supplemental Assay 20t FDA UDI
Model / Reference
72480 FDA UDI
Description
Geenius HIV 1/2 Supplemental Assay 20t FDA UDI

Identifiers

Catalog Number
72480 FDA UDI
Primary DI / UDI-DI
03610521168942 FDA UDI
FDA Product Code
QHM FDA UDI
GMDN Term
HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
610.40 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

Yes

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

No

FDA UDI

Category: HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 176a7b56-48e3-422c-ba1c-f933a9140258 36 fields · synced Jun 8, 2026