Strep-A-Chek(TM) Strips (100 pcs)

Primary DI
00863251000225
Brand
Strep-A-Chek(TM) Strips (100 pcs)
Company
E-Y Laboratories, Inc.
Model
13-051-00
Catalog number
13-051-00
Device description
Strep-A-Chek™ Reagent Strips are paper strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl arylamidase (PYR), an enzyme reported to be present in Group A beta-hemolytic Streptococcus. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. Strep-A-Chek™ kit when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of beta-hemolytic streptococci or enterococci from any source.Strep-A-Chek™ Reagent Strips are a component of the Strep-A-Chek™ Kit (Cat. No: 13-050-00) and are to be used with EY-20™ Reagent Tubes. They are intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on blood agar plates, as an aid in the presumptive identification of Group A Streptococcus.
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863251000225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863251000225008632510002258632510002250863251000225

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6503423296orders@eylabs.com

Regulatory Flags#

DUNS number
087212858
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863251000201Strep-A-Chek(TM) Kit13-050-0013-050-002023-09-01
00863251000218 Gonochek®-II Reagent Tubes13-003-252023-09-01
00863251000232EY-20(TM) Reagent Tube13-020-5013-020-502023-09-01