N/A - PYR Test Kit, with 15ml chromogenic solution and - HARDY DIAGNOSTICS

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

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More Product Details

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

Product Characteristics

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 Details

Product Code

JTO

Product Code Name

Discs, Strips And Reagents, Microorganism Differentiation

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARDY DIAGNOSTICS" Characteristics
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