N/A

Primary DI
00850041798004
Brand
N/A
Company
Key Scientific Products Incorporated
Model
K1538B
Device description
For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity within a short period.
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041798004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041798004008500417980048500417980040850041798004

GMDN Terms#

Term, Definition table
TermDefinition
Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of pyrrolidonyl arylamidase (PYR) activity in a clinical specimen and/or culture isolate within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test used in the laboratory or in point-of-care analyses typically to differentiate Group A streptococci and enterococci from Group D streptococci. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
783601115
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041798059N/AKS70WH502023-12-18
00850041798042N/AK9823752023-10-25
00850041798011N/AKF40122023-09-08
00850041798028N/AK9823752023-09-08
00850041798035N/AK1538B2023-09-07