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Aimscreen Bzo

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSCREEN BZO FDA UDI
Generic Name
Benzodiazepine group IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Lateral flow immunoassay for the detection of Benzodiazepines (BZO) in urine FDA UDI
Model / Reference
42325 FDA UDI
Description
Lateral flow immunoassay for the detection of Benzodiazepines (BZO) in urine FDA UDI

Identifiers

Primary DI / UDI-DI
00695684423254 FDA UDI
FDA Product Code
JXM FDA UDI
GMDN Term
Benzodiazepine group IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3170 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Benzodiazepine group IVD, kit, rapid ICT, clinical

Aimscreen Bzo by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Benzodiazepine group IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI eb67e332-df77-46da-84b8-77daf284e3ee 33 fields · synced May 30, 2026