Identity
- Trade Name
- Spotted Fever Rickettsia IgG ELISA Kit FDA UDI
- Generic Name
- Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- An EIA assay for spotted fever Rickettsiosis IgG levels FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- An EIA assay for spotted fever Rickettsiosis IgG levels FDA UDI
Identifiers
- Catalog Number
- SFG96K FDA UDI
- Primary DI / UDI-DI
- B266SFG96K0 FDA UDI
- GMDN Term
- Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
Yes
FDA UDI
Spotted Fever Rickettsia IgG ELISA Kit by Fuller Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fuller Laboratories, Inc.
Sources (1)
- FDA UDI 7431c521-2bbd-4232-a856-817e9f551dd7 35 fields · synced Jun 1, 2026