Identity
- Trade Name
- Pseudomonas-CF-IgG antigen pool, lyophilized FDA UDI
- Generic Name
- Pseudomonas aeruginosa antigen IVD, control FDA UDI
- Device Name
- Human-antisera, Pseudomonas-CF-IgG FDA UDI
- Model / Reference
- 60899 FDA UDI
- Description
- Human-antisera, Pseudomonas-CF-IgG FDA UDI
Identifiers
- Catalog Number
- 60899 FDA UDI
- Primary DI / UDI-DI
- 05713106608999 FDA UDI
- FDA Product Code
- GSS FDA UDI
- GMDN Term
- Pseudomonas aeruginosa antigen IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3415 FDA UDI
- Commercial Distribution
- Not 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
No
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
Pseudomonas-CF-IgG antigen pool, lyophilized by Ssi Diagnostica A/S — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ssi Diagnostica A/S
Sources (1)
- FDA UDI 79421f39-d3ab-4870-8121-eeda22b91858 35 fields · synced May 31, 2026