Genemed® - A/B Block Kit (Avidin/Biotin Blocking Solution), - SAKURA FINETEK U.S.A., INC.

Duns Number:179135769

Device Description: A/B Block Kit (Avidin/Biotin Blocking Solution), Ready-To-Use, 15 mL each

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More Product Details

Catalog Number

10-0039

Brand Name

Genemed®

Version/Model Number

10-0039

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

PPM

Product Code Name

General purpose reagent

Device Record Status

Public Device Record Key

bf4010c7-8321-4eb4-a092-512deaf815fa

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 28, 2019

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