Identity
- Trade Name
- Prolex Strep Enzyme Kit FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDI
- Device Name
- The Prolex™ Strep Enzyme Kit provides a rapid platform for the serological identification of beta-haemolytic streptococci belonging to Lancefield groups A, B, C, D, F and G. FDA UDI
- Model / Reference
- PL.1050 FDA UDI
- Description
- The Prolex™ Strep Enzyme Kit provides a rapid platform for the serological identification of beta-haemolytic streptococci belonging to Lancefield groups A, B, C, D, F and G. FDA UDI
Identifiers
- Catalog Number
- PL.1050 FDA UDI
- Primary DI / UDI-DI
- 10628429001377 FDA UDI
- FDA Product Code
- GTZ FDA UDI
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 FDA UDI
- 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
No
FDA UDI
Category: Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination
Prolex Strep Enzyme Kit by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination.
- BD BBL™ Streptocard™ Enzyme G Test Latex — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Streptocard™ Enzyme C Test Latex — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Streptocard™ Acid Latex Test Kit — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Streptocard™ Enzyme F Test Latex — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Streptocard™ Enzyme Latex Test Kit — BECTON DICKINSON AND COMPANY · Class I
- Prolex Streptococcal Grouping Reagent Extraction Reagent 1 — PRO-LAB, INCORPORATED · Class I
- Prolex Extraction Reagent Set — PRO-LAB, INCORPORATED · Class I
- Prolex Streptococcal Grouping Reagent Latex Suspension Group D — PRO-LAB, INCORPORATED · Class I
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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI 7a343ea7-b49e-4289-8b35-7730043c18ba 34 fields · synced May 31, 2026