CENMED - CenMed hCG Serum Control POSITIVE, 5mL - BIOCHEMICAL DIAGNOSTICS INC

Duns Number:028007698

Device Description: CenMed hCG Serum Control POSITIVE, 5mL

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More Product Details

Catalog Number

18000698

Brand Name

CENMED

Version/Model Number

2122015

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

-

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

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

7a4b060f-628b-4180-a862-34afb33bddc2

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCHEMICAL DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388