H. influenzae Type b serum, 1 mL - 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

3462

Brand Name

H. influenzae Type b serum, 1 mL

Version/Model Number

3462

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2021

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

GRP

Product Code Name

Antisera, All Types, H. Influenza

Device Record Status

Public Device Record Key

6eca014d-3328-48f4-ba4c-cc65ab4c613c

Public Version Date

June 17, 2021

Public Version Number

4

DI Record Publish Date

September 13, 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