FITC Anti-Rabies Monoclonal Globulin - FUJIREBIO DIAGNOSTICS, INC.

Duns Number:079291908

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More Product Details

Catalog Number

-

Brand Name

FITC Anti-Rabies Monoclonal Globulin

Version/Model Number

800-092

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)

Yes

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

GOI

Product Code Name

Antiserum, Fluorescent, Rabies Virus

Device Record Status

Public Device Record Key

c26056a8-9807-474a-a39f-c8fefdf7c213

Public Version Date

July 15, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJIREBIO DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 5