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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 SW V2.0 & APF V2.0 Installation Kit FDA UDI
Model / Reference
12012851 FDA UDI
Description
Geenius SW V2.0 & APF V2.0 Installation Kit FDA UDI

Identifiers

Catalog Number
12012851 FDA UDI
Primary DI / UDI-DI
03610522168064 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

No

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

No

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 619cf42a-f5bb-418f-b193-04ad802b0a89 36 fields · synced May 30, 2026