OEM 81-13 Drug Test 6 Panel Test Cup U-CUP-264

GUDID 20817038022232

OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID20817038022232
NIH Device Record Keydae59595-d096-4d96-8873-69ad54ce0d43
Commercial Distribution Discontinuation2034-04-08
Commercial Distribution StatusIn Commercial Distribution
Brand NameOEM 81-13 Drug Test 6 Panel Test Cup
Version Model NumberU-CUP-264
Catalog NumberU-CUP-264
Company DUNS163610020
Company NameUCP BIOSCIENCES, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817038022238 [Unit of Use]
GS110817038022235 [Primary]
GS120817038022232 [Package]
Contains: 10817038022235
Package: case [8 Units]
Discontinued: 2034-04-08
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-17
Device Publish Date2024-04-09

Devices Manufactured by UCP BIOSCIENCES, INC.

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