Identity
- Trade Name
- Phadebact Strep F Test FDA UDI
- Generic Name
- Multiple Beta-haemolytic Streptococcus serogroup antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- 10-5587-12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350049850207 FDA UDI
- FDA Product Code
- GTZ FDA UDI
- GMDN Term
- Multiple Beta-haemolytic Streptococcus serogroup antigen 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple Beta-haemolytic Streptococcus serogroup antigen IVD, kit, agglutination
The Phadebact Strep F Test is a diagnostic tool for detecting Beta-haemolytic Streptococcus serogroup antigen IVD, used in clinical settings to identify the presence of strep infections. Developed by Mkl Diagnostics AB, this device has undergone rigorous testing and meets strict regulatory standards for safety and efficacy.
Similar devices
Also classified as Multiple Beta-haemolytic Streptococcus serogroup antigen IVD, kit, agglutination.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mkl Diagnostics AB
Sources (1)
- FDA UDI 2e4cdd80-bd41-443b-a816-b7f7302bc4bb 33 fields · synced Jul 29, 2026