Identity
- Trade Name
- Strep-A-Chek(TM) Strips (100 pcs) FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 13-051-00 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 13-051-00 FDA UDI
- Primary DI / UDI-DI
- 00863251000225 FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Strep-A-Chek(TM) Strips (100 pcs) by E-Y Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- E-Y Laboratories, Inc.
Sources (1)
- FDA UDI 30533935-bc00-439a-b9ed-eac7c44e4e1e 36 fields · synced May 30, 2026