Identity
- Trade Name
- ImmuLex Streptococcus Group A, 1.5 mL FDA UDI
- Generic Name
- Multiple Streptococcus species antigen IVD, antibody FDA UDI
- Device Name
- Rabbit antiserum, Ready to use FDA UDI
- Model / Reference
- 73258 FDA UDI
- Description
- Rabbit antiserum, Ready to use FDA UDI
Identifiers
- Catalog Number
- 73258 FDA UDI
- Primary DI / UDI-DI
- 05713106732588 FDA UDI
- FDA Product Code
- GTZ FDA UDI
- GMDN Term
- Multiple Streptococcus species antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 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
ImmuLex Streptococcus Group A, 1.5 mL by Ssi Diagnostica A/S — 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
- Ssi Diagnostica A/S
Sources (1)
- FDA UDI 5f42edda-fc83-4d18-88b6-939e06df44c7 37 fields · synced May 31, 2026