Identity
- Trade Name
- Rickettsia rickettsii (RMSF) Latex 30 Test Ki FDA UDI
- Generic Name
- Rickettsia rickettsii antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- L-RRS01T FDA UDI
Identifiers
- Catalog Number
- L-RRS01T FDA UDI
- Primary DI / UDI-DI
- 00813545026295 FDA UDI
- FDA Product Code
- LSQ FDA UDI
- GMDN Term
- Rickettsia rickettsii antigen IVD, kit, agglutination 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
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: Rickettsia rickettsii antigen IVD, kit, agglutination
Rickettsia rickettsii (RMSF) Latex 30 Test Ki by Scimedx Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rickettsia rickettsii antigen IVD, kit, agglutination.
- R. Rickettsii 12 well; 10 pk — Scimedx Corp. · 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 |
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Manufacturer
- Manufacturer
- Scimedx Corp.
Sources (1)
- FDA UDI 1791f422-ac9e-48fc-bff0-7faa348bb5d9 34 fields · synced Jun 8, 2026