Catalog Number

-

Brand Name

Phadebact CSF Positive Controls

Version/Model Number

10-5593-12

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GTZ

Product Code Name

Antisera, All Groups, Streptococcus Spp.

Public Device Record Key

54da30d5-9cfd-40b5-8769-6b879a1ac1b4

Public Version Date

September 20, 2018

Public Version Number

1

DI Record Publish Date

August 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-