Healgen (Private Label) FLATCUP-6125A3 - 12 Panel Flat-Cup w/ADU - CONFIRM BIOSCIENCES, INC.

Duns Number:806524968

Device Description: 12 Panel Flat-Cup w/ADU (AMP/COC/OXY/THC/PCP/MDMA/MOR/BZO/BAR/MTD/mAMP/BUP+A3)

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More Product Details

Catalog Number

-

Brand Name

Healgen (Private Label) FLATCUP-6125A3

Version/Model Number

CB-HE-FLATCUP-6125A3C

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

1ef147a9-34bd-4d0d-9804-bc46ed5343a4

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONFIRM 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. 36