AmediCheck Instant Test Cup C-C1016A

• • Terminated Z-0270-2019 FDA Class III ·initiated 30 Sep 2017

  Product was released to market without the adulteration strip included in the product.

• • Terminated Z-2311-2016 FDA Class III ·initiated 5 Jul 2016

  Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.

Trade Name

AmediCheck Instant Test Cup

Generic Name

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Model / Ref / Catalog

C-C1016A

Primary DI / UDI-DI

00816555020253

510(k) Number

K063379 ↗

K082898 ↗

FDA Product Code

JXM, DJC, DIO, LDJ, DJG, DJR, NFV, DIS, NGG, NGL, NFY, NFW, NFT, DKZ

GMDN Term

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device Class

Class II

Regulation Number

862.3170, 862.3610, 862.3250, 862.3870, 862.3650, 862.3620, 862.3150, 862.3100

Commercial Distribution

Not in Commercial Distribution

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