Identity
- Trade Name
- R. Rickettsii 12 well; 10 pk FDA UDI
- Generic Name
- Rickettsia rickettsii antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- I-RRS01X FDA UDI
Identifiers
- Catalog Number
- I-RRS01X FDA UDI
- Primary DI / UDI-DI
- 00813545026110 FDA UDI
- FDA Product Code
- LSQ FDA UDI
- GMDN Term
- Rickettsia rickettsii antigen IVD, kit, agglutination FDA UDI
- Models / Variants
- R. Rickettsii 12 well FDA UDI10 pk FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3500 FDA UDI
- Commercial Distribution
- 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
Category: Rickettsia rickettsii antigen IVD, kit, agglutination
R. Rickettsii 12 well +1 more model by Scimedx Corp. — Class I — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Rickettsia rickettsii antigen IVD, kit, agglutination.
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
- Scimedx Corp.
Sources (1)
- FDA UDI b808111d-ac5b-43e1-8470-927f681da3e1 34 fields · synced May 30, 2026