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Aimstrip Alcohol Saliva

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSTRIP ALCOHOL SALIVA FDA UDI
Generic Name
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Semi-quantitative test for blood alcohol concentration FDA UDI
Model / Reference
40070 FDA UDI
Description
Semi-quantitative test for blood alcohol concentration FDA UDI

Identifiers

Primary DI / UDI-DI
00695684400705 FDA UDI
FDA Product Code
DIC FDA UDI
GMDN Term
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3040 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: Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical

Aimstrip Alcohol Saliva by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ethanol (ETOH) IVD, kit, rapid colorimetric, 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 8fdc7a34-1019-4eed-af0b-047ae7cc16e5 33 fields · synced Jun 8, 2026