Identity
- Trade Name
- Phadebact Pneumococcus Test FDA UDI
- Generic Name
- Streptococcus pneumoniae antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- 10-5576-12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350049850122 FDA UDI
- FDA Product Code
- GWC FDA UDI
- GMDN Term
- Streptococcus pneumoniae 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
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Streptococcus pneumoniae antigen IVD, kit, agglutination
Phadebact Pneumococcus Test by Mkl Diagnostics AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Mkl Diagnostics AB
Sources (1)
- FDA UDI f043b54f-b931-4852-a766-dc7b216e99f3 33 fields · synced May 30, 2026