Duns Number:039981550
Device Description: StrepPRO™ Extraction Reagent 3, for the rapid latex agglutination test, 60 testsExtraction StrepPRO™ Extraction Reagent 3, for the rapid latex agglutination test, 60 testsExtraction 1 Reagent for the rapid latex agglutination test for the identification of streptococcal groups.
Catalog Number
PL039HD
Brand Name
StrepPRO™
Version/Model Number
PL039HD
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
GTZ
Product Code Name
Antisera, All Groups, Streptococcus Spp.
Public Device Record Key
98744bb3-3584-4ae7-9e17-1f91da9e476b
Public Version Date
September 10, 2020
Public Version Number
1
DI Record Publish Date
September 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |