Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC - Instant-View Multi-Drug of Abuse Urine Cup - ALFA SCIENTIFIC DESIGNS, INC.

Duns Number:176391167

Device Description: Instant-View Multi-Drug of Abuse Urine Cup TestAMP COC MET MOR/OPI PCP THC

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC

Version/Model Number

03-4438

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

1f38b626-6dc1-4a5e-a04c-d3fd2aa520d8

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALFA SCIENTIFIC DESIGNS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 10