ZORBA IgG Removal Reagent - Zorba® IgG Removal Reagent is designed to - ZEUS SCIENTIFIC, INC.

Duns Number:080953946

Device Description: Zorba® IgG Removal Reagent is designed to functionally remove potentially interfering immu Zorba® IgG Removal Reagent is designed to functionally remove potentially interfering immunoglobulin G (IgG) antibodies from human serum prior to testing for IgM. The product is for In Vitro diagnostic use.

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More Product Details

Catalog Number

FA003G

Brand Name

ZORBA IgG Removal Reagent

Version/Model Number

FA003G

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)

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

da5ce6c7-0aa8-423a-90bb-85431d36d052

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZEUS SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1