Catalog Number

IDSTREP-25

Brand Name

Detector Strep A

Version/Model Number

IST-501-OBC33

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)

Yes

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

0566f7ef-181d-47fa-830f-2cd257c72b14

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20722355001665

Quantity per Package

10

Contains DI Package

10722355001668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 10