UCP Compact Drug Test Cups - UCP Compact Drug Test Cups 10-Panel Drug Test Cup - UCP BIOSCIENCES, INC.

Duns Number:163610020

Device Description: UCP Compact Drug Test Cups 10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP UCP Compact Drug Test Cups 10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP with Adulteration strip (S.G./CRE/pH)

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More Product Details

Catalog Number

UCC-A1001M-A3A

Brand Name

UCP Compact Drug Test Cups

Version/Model Number

UCC-A1001M-A3A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131811,K131811,K131811

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

776207dd-905a-43ab-855b-ce029dbf6126

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 26, 2018

Additional Identifiers

Package DI Number

20817038021976

Quantity per Package

8

Contains DI Package

10817038021979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"UCP BIOSCIENCES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2