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AmediCheck Instant Test Cup

FDA UDI

Class II (US FDA UDI)

by Ameditech Inc.

Identity

Trade Name
AmediCheck Instant Test Cup FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
COC, OPI300, AMP, MET, BZO, OXY with Adulteration Screen for OX/SG/PH FDA UDI
Model / Reference
C-C0611A-3A FDA UDI
Description
COC, OPI300, AMP, MET, BZO, OXY with Adulteration Screen for OX/SG/PH FDA UDI

Identifiers

Catalog Number
C-C0611A-3A FDA UDI
Primary DI / UDI-DI
00816565020540 FDA UDI
510(k) Number
K063379 FDA UDI
K082898 FDA UDI
FDA Product Code
JXM FDA UDI
DKZ FDA UDI
DIO FDA UDI
DJG FDA UDI
NFV FDA UDI
DJC FDA UDI
NGG FDA UDI
NFY FDA UDI
NFT FDA UDI
NGL FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3170 FDA UDI
862.3100 FDA UDI
862.3250 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Convenience Kit

Yes

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

AmediCheck Instant Test Cup by Ameditech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K063379 also covers:

K082898 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ameditech Inc.

Sources (1)

  • FDA UDI 0b0d3ca0-3232-4985-a17e-75020a844e2b 38 fields · synced May 31, 2026