Identity
- Trade Name
- Autostat II Anti-ENA-6 Profile FDA UDI
- Generic Name
- Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 96 well ELISA for the detection of ENA antibodies in human serum FDA UDI
- Model / Reference
- FGA38 FDA UDI
- Description
- 96 well ELISA for the detection of ENA antibodies in human serum FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816879020380 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen (ENA) 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Autostat II Anti-ENA-6 Profile by Hycor Biomedical Llc — 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
- Hycor Biomedical Llc
Sources (1)
- FDA UDI 080c4624-29a3-4cf4-9ad2-03fb993403f7 36 fields · synced May 31, 2026