Tinto Hepatitis B Virus Surface Antigen, MMab - Tinto Hepatitis B Virus Surface Antigen (HBsAg) - BIO SB, INC.

Duns Number:102855447

Device Description: Tinto Hepatitis B Virus Surface Antigen (HBsAg) is a mouse monoclonal antibody derived fro

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More Product Details

Catalog Number

BSB 5618

Brand Name

Tinto Hepatitis B Virus Surface Antigen, MMab

Version/Model Number

Predilute, 7 ml

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

MVU

Product Code Name

Reagents, Specific, Analyte

Device Record Status

Public Device Record Key

4437cd83-8a2c-46bd-9b90-d3383729b41f

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO SB, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3887