Identity
- Trade Name
- AUTO I.D.® Sm/RNP Autoantibody Test System FDA UDI
- Generic Name
- Multiple extractable nuclear antigen (ENA) IVD, control FDA UDI
- Device Name
- AUTO I.D.® Universal Antigen - 1 x 0.2 ml FDA UDI
- Model / Reference
- 6050 (1) FDA UDI
- Description
- AUTO I.D.® Universal Antigen - 1 x 0.2 ml FDA UDI
Identifiers
- Catalog Number
- 6050 (1) FDA UDI
- Primary DI / UDI-DI
- M7490605011 FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen (ENA) IVD, control 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple extractable nuclear antigen (ENA) IVD, control
AUTO I.D.® Sm/RNP Autoantibody Test System by Immuno Concepts Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple extractable nuclear antigen (ENA) IVD, control.
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Immuno Concepts Inc
Sources (1)
- FDA UDI 286c1ba5-e889-473a-b66f-b0128ead7443 34 fields · synced May 31, 2026