Toxoplasma gondii RPab - Anti-Toxoplasma is a purified immunoglobulin - BIO SB, INC.

Duns Number:102855447

Device Description: Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter s Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5

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More Product Details

Catalog Number

BSB 6046

Brand Name

Toxoplasma gondii RPab

Version/Model Number

Concentrate, 0.1 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

98c03a87-660e-4574-897e-38ec68330242

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 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