u-Card TM Drug Test Screen 7 panel Test Card U-DOA-374L

GUDID 10817038022013

u-Card TM Drug Test Screen 7 panel Test Card COC/AMP/MET/THC/OPI/BZO/OXY

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10817038022013
NIH Device Record Keyb8e67e0e-c258-43e1-900e-f8634c464eae
Commercial Distribution StatusIn Commercial Distribution
Brand Nameu-Card TM Drug Test Screen 7 panel Test Card
Version Model NumberU-DOA-374L
Catalog NumberU-DOA-374L
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
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
GS100817038022016 [Unit of Use]
GS110817038022013 [Primary]
GS120817038022010 [Package]
Package: Case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJCThin Layer Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-02-29

Devices Manufactured by UCP BIOSCIENCES, INC.

20817038022225 - OEM 81-13 Drug Test 5 Panel Test Cup2024-04-17 OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO
20817038022232 - OEM 81-13 Drug Test 6 Panel Test Cup2024-04-17 OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI
20817038022218 - u-CardTM Drug Test Screen 12 Panel Test Card 2024-01-12 u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
20817038022201 - UCP2023-12-18 UCP Drug Test Mini Cups 9-Panel Drug Test Mini Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
20817038021020 - UCP Home Pregnancy Dip Card2023-07-06 Pregnancy Dip Card
20817038021211 - UCP HOME2023-07-06 UCP HOME Pregnancy Test Strip
20817038021266 - UCP Home2023-07-06 UCP HOME Pregnancy Test Strip
20817038021884 - UCP Home Pregnancy Test Cassette2023-07-06 UCP Home Pregnancy Test Cassette
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.