CA19-9 (121SLE) Mouse Monoclonal Antibody - CELL MARQUE CORPORATION

Duns Number:025048773

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More Product Details

Catalog Number

-

Brand Name

CA19-9 (121SLE) Mouse Monoclonal Antibody

Version/Model Number

399M-17

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

NJT

Product Code Name

Immunohistochemistry Reagents And Kits

Device Record Status

Public Device Record Key

c356cf26-7de6-432b-80fd-9cd54f459f20

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CELL MARQUE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 984