OEM 81-13 Drug Test U-DOA-134

GUDID 20817038022126

OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC

UCP BIOSCIENCES, INC.

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Primary Device ID20817038022126
NIH Device Record Keye9b545c4-ef04-420c-9fec-9331dc428bf7
Commercial Distribution Discontinuation2033-04-06
Commercial Distribution StatusIn Commercial Distribution
Brand NameOEM 81-13 Drug Test
Version Model NumberU-DOA-134
Catalog NumberU-DOA-134
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
GS100817038022122 [Unit of Use]
GS110817038022129 [Primary]
GS120817038022126 [Package]
Contains: 10817038022129
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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