Salmonella Latex Kit - MICROGEN BIOPRODUCTS LIMITED

Duns Number:231128802

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More Product Details

Catalog Number

-

Brand Name

Salmonella Latex Kit

Version/Model Number

M42CE

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

GRM

Product Code Name

Antisera, All Groups, Salmonella Spp.

Device Record Status

Public Device Record Key

52f7bfe8-5db8-41de-8072-4620e0f28fb7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROGEN BIOPRODUCTS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6