S. Montevideo reference strain - Reference strain - Ssi Diagnostica A/S

Duns Number:305684449

Device Description: Reference strain

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


More Product Details

Catalog Number

82160

Brand Name

S. Montevideo reference strain

Version/Model Number

82160

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)

-

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

GRL

Product Code Name

Antigens, All Groups, Salmonella Spp.

Device Record Status

Public Device Record Key

9e8cae5b-6bea-4ba8-9d21-b2e963de5923

Public Version Date

August 05, 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