Catalog Number

82241

Brand Name

S. pneumoniae reference strain 33F

Version/Model Number

82241

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

GTY

Product Code Name

ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Public Device Record Key

6ac170e1-8367-48ef-9249-07df2c67905b

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

August 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-