Identity
- Trade Name
- Proteus OX19 Agglutinating Serum FDA UDI
- Generic Name
- Multiple Rickettsia species (spotted fever group) total antibody IVD, control FDA UDI
- Model / Reference
- R30165801 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501604 FDA UDI
- FDA Product Code
- GSY FDA UDI
- GMDN Term
- Multiple Rickettsia species (spotted fever group) total antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3410 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
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
Category: Multiple Rickettsia species (spotted fever group) total antibody IVD, control
Proteus OX19 Agglutinating Serum by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Rickettsia species (spotted fever group) total antibody IVD, control.
- Proteus OXK Agglutinating Serum — REMEL EUROPE LIMITED · Class I
- Proteus OX2 Agglutinating Serum — REMEL EUROPE LIMITED · 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
- Remel Europe Limited
Sources (1)
- FDA UDI fb95049e-b5ab-4357-93c7-3440035efe5a 33 fields · synced Jun 8, 2026