Identity
- Trade Name
- ImmunoDOT Autoimmunity Panel 4 FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. FDA UDI
- Model / Reference
- 800-5489 FDA UDI
- Description
- The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. FDA UDI
Identifiers
- Catalog Number
- 5489 FDA UDI
- Primary DI / UDI-DI
- 00613745054896 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ImmunoDOT Autoimmunity Panel 4 by Genbio — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Genbio
Sources (1)
- FDA UDI 51931a6c-3af8-4e17-b10b-4c7f75e230bf 38 fields · synced May 29, 2026