Identity
- Trade Name
- IMMUNODOT™ RICKETTSIA CONORII FDA UDI
- Generic Name
- Rickettsia conorii total antibody IVD, kit, immunoblot FDA UDI
- Device Name
- The GenBio ImmunoDOT Rickettsia conorii (Mediterranean Spotted Fever) test is a semi-quantitative enzyme immunoassay for the detection of total IgG and IgM antibodies to Rickettsia conorii for the serological confirmation from serum, plasma or heparinized whole blood. This test is intended to be performed by trained medical technologists only. FDA UDI
- Model / Reference
- 800-4010 FDA UDI
- Description
- The GenBio ImmunoDOT Rickettsia conorii (Mediterranean Spotted Fever) test is a semi-quantitative enzyme immunoassay for the detection of total IgG and IgM antibodies to Rickettsia conorii for the serological confirmation from serum, plasma or heparinized whole blood. This test is intended to be performed by trained medical technologists only. FDA UDI
Identifiers
- Catalog Number
- 4010 FDA UDI
- Primary DI / UDI-DI
- 00613745000015 FDA UDI
- FDA Product Code
- LSQ FDA UDI
- GMDN Term
- Rickettsia conorii total antibody IVD, kit, immunoblot 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
Yes
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
No
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 conorii total antibody IVD, kit, immunoblot
Immunodot™ Rickettsia Conorii by Genbio — 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
- Genbio
Sources (1)
- FDA UDI 057eb179-2506-4aea-adbe-29bcb77a8bdd 37 fields · synced Jun 8, 2026