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Accutest Breath Alcohol Detector

FDA UDI

Class I (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
Accutest Breath Alcohol Detector FDA UDI
Generic Name
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Breath Alcohol Detector, .02 % BAC. FDA UDI
Model / Reference
DS95AC220 FDA UDI
Description
Breath Alcohol Detector, .02 % BAC. FDA UDI

Identifiers

Primary DI / UDI-DI
10763924095213 FDA UDI
510(k) Number
K093143 FDA UDI
FDA Product Code
DJZ FDA UDI
GMDN Term
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3050 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

Accutest Breath Alcohol Detector by Jant Pharmacal Corp. — Class I — 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
Jant Pharmacal Corp.

Sources (1)

  • FDA UDI 0ee0a99f-ea6e-4012-b222-8c2a45eed482 34 fields · synced May 31, 2026