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Mission Saliva Test Strips

FDA UDI

Class II (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
Mission Saliva Test Strips FDA UDI
Generic Name
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Mission Saliva Alcohol Test Strips FDA UDI
Model / Reference
C031-021 FDA UDI
Description
Mission Saliva Alcohol Test Strips FDA UDI

Identifiers

Primary DI / UDI-DI
00682607200054 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

Yes

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

Mission Saliva Test Strips by ACON 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.

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
ACON Laboratories, Inc.

Sources (1)

  • FDA UDI 96e37f4c-a20f-4aa8-8822-24304df923e0 36 fields · synced Jun 9, 2026