Salmonella Sero-Quick Group Kit - Rabbit antisera. Ready-To-Use. - Ssi Diagnostica A/S

Duns Number:305684449

Device Description: Rabbit antisera. Ready-To-Use.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

62984

Brand Name

Salmonella Sero-Quick Group Kit

Version/Model Number

62984

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2020

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)

-

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

9d76442a-0ba8-4de5-bfd3-a59281b1bc65

Public Version Date

June 15, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SSI DIAGNOSTICA A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1152
2 A medical device with a moderate to high risk that requires special controls. 272