Duns Number:039981550
Device Description: PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have 3 tests pe PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have 3 tests per card, total of 75 tests per kitHardy Diagnostics PYR Test Kit and PYR Reagent are recommended for the detection of pyrolidonyl arylamidase (also called pyrolidonyl aminopeptidase) activity in certain groups of bacteria, such as Streptococcus pyogenes (group A strep), Enterococcus spp., some coagulase-negative staphylococci, and some Enterobacteriaceae.The card format is easier to handle than disks. Three tests can be performed on one card.Contains:PYR Test Card (25) 00819398027144PYR Chromagenic Solution 15mL (1) 00819398028660
Catalog Number
Z275
Brand Name
N/A
Version/Model Number
Z275
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
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
89b3e03f-158e-477a-bf9c-7be922927d54
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 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 |