OEM 81-13 Drug Test U-DOA-654

GUDID 20817038022133

OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/BZO

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID20817038022133
NIH Device Record Key9509fd22-612d-4972-9387-0b77d8ac6790
Commercial Distribution Discontinuation2033-04-06
Commercial Distribution StatusIn Commercial Distribution
Brand NameOEM 81-13 Drug Test
Version Model NumberU-DOA-654
Catalog NumberU-DOA-654
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
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
GS100817038022139 [Unit of Use]
GS110817038022136 [Primary]
GS120817038022133 [Package]
Contains: 10817038022136
Package: case [50 Units]
Discontinued: 2023-04-06
Not 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 Date2023-04-17
Device Publish Date2023-04-07

On-Brand Devices [OEM 81-13 Drug Test ]

20817038022164OEM 81-13 Drug Test 4 Panel Dip Card AMP/COC/THC/MET
20817038022157OEM 81-13 Drug Test 6 Panel Dip Card AMP/COC/THC/MET/BZO/OPI
20817038022140OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/OPI
20817038022133OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/BZO
20817038022126OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC

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