ToxCup Drug Screen Cup PT15

• • Terminated Z-3045-2020 FDA Class II ·initiated 18 Aug 2020

  Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

• • Terminated Z-1508-2014 FDA Class II ·initiated 26 Mar 2014

  May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

Trade Name

ToxCup Drug Screen Cup

Generic Name

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

Model / Ref / Catalog

PT15

Primary DI / UDI-DI

00816555020574

510(k) Number

K032057 ↗

FDA Product Code

LDJ, DJG, DJC, DIO, DKZ

GMDN Term

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

Device Class

Class II

Regulation Number

862.3870, 862.3650, 862.3610, 862.3250, 862.3100

Commercial Distribution

Not in Commercial Distribution

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