Tissue-Tek Genie® - anti-ZAP70 Mouse Monoclonal Antibody [ZM97], 10 - SAKURA FINETEK U.S.A., INC.

Duns Number:179135769

Device Description: anti-ZAP70 Mouse Monoclonal Antibody [ZM97], 10 RTU capsules

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More Product Details

Catalog Number

8501-C010

Brand Name

Tissue-Tek Genie®

Version/Model Number

8501-C010

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

NJT

Product Code Name

IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Device Record Status

Public Device Record Key

57f4363d-d69f-400b-a92c-409312f96b20

Public Version Date

March 11, 2020

Public Version Number

1

DI Record Publish Date

March 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAKURA FINETEK U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 733