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Accustrip Saliva Alcohol Test

FDA UDI

Class II (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
Accustrip Saliva Alcohol Test FDA UDI
Generic Name
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Saliva Alcohol Test Strip FDA UDI
Model / Reference
DS97AC125 FDA UDI
Description
Saliva Alcohol Test Strip FDA UDI

Identifiers

Primary DI / UDI-DI
10763924097224 FDA UDI
510(k) Number
K093879 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

No

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

Accustrip Saliva Alcohol Test by Jant Pharmacal Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K093879 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jant Pharmacal Corp.

Sources (1)

  • FDA UDI e3b205d3-6bdd-4ebc-a047-270431172204 34 fields · synced Jun 6, 2026