EY-20(TM) Reagent Tube
Basic Information
- Brand Name
- EY-20(TM) Reagent Tube
- Primary DI
- 00863251000232
- Version / Model
- 13-020-50
- Catalog Number
- 13-020-50
- Company Name
- E-Y Laboratories, Inc.
- Labeler DUNS
- 087212858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-01
- Public Version
- 1
- Public Version Date
- 2023-09-11
- Public Version Status
- New
- Public Device Record Key
- b5cc6f6d-08b5-46f2-8456-9ce1d6c29fd2
Device Description
The EY-20™ Reagent Tubes are a component of the Strep-A-Chek™ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chek™ Reagent Strips. 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. EY-20™ Reagent Tubes contain a color developer, which when used with the Strep-A-Chek™ Reagent Strips detect pyrrolidonyl arylamidase (PYR), an enzyme 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. The Strep-A-Chek™ test system, when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of streptococci or enterococci from any source.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51707 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00863251000232 | GS1 |
Customer Contacts
- Phone
- 6503423296
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 8 Degrees Celsius