Strep-A-Chek(TM) Kit
- Primary DI
- 00863251000201
- Brand
- Strep-A-Chek(TM) Kit
- Company
- E-Y Laboratories, Inc.
- Model
- 13-050-00
- Catalog number
- 13-050-00
- Device description
- Strep-A-Chek™ Kit is 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.Strep-A-Chek™ consists of Strep-A-Chek™ Reagent 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, and EY-20™ Reagent Tubes which contain a diazo dye color developer, Fast Garnet. 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.
- 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#
eylabs.comIdentifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00863251000201 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00863251000201 | 00863251000201 | 863251000201 | 0863251000201 |
GMDN Terms#
| Term | Definition |
|---|---|
| Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical | A 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 | Condition |
|---|---|---|---|
| Storage Environment Temperature | 5 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 6503423296 | orders@eylabs.com |
Regulatory Flags#
- DUNS number
- 087212858
- Device count
- 1
- Premarket exempt
- true
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00863251000218 | Gonochek®-II Reagent Tubes | 13-003-25 | 2023-09-01 | |
| 00863251000225 | Strep-A-Chek(TM) Strips (100 pcs) | 13-051-00 | 13-051-00 | 2023-09-01 |
| 00863251000232 | EY-20(TM) Reagent Tube | 13-020-50 | 13-020-50 | 2023-09-01 |