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AmediCheck Instant Test Cup

FDA UDI

Class U (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
THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH FDA UDI
Model / Reference
C-C0502A-3A FDA UDI
Description
THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH FDA UDI

Identifiers

Catalog Number
C-C0502A-3A FDA UDI
Primary DI / UDI-DI
00816565020519 FDA UDI
510(k) Number
K063379 FDA UDI
K082898 FDA UDI
FDA Product Code
LCM FDA UDI
NGG FDA UDI
DJC FDA UDI
DJG FDA UDI
DIO FDA UDI
LDJ FDA UDI
NFW FDA UDI
NGL FDA UDI
NFY FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3610 FDA UDI
862.3650 FDA UDI
862.3250 FDA UDI
862.3870 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 U — 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 d2ebef5c-f856-44a0-9ca2-5a3eb9ba739a 38 fields · synced May 30, 2026