Identity
- Trade Name
- AUTO I.D.® Sm/RNP Autoantibody Test System FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion FDA UDI
- Device Name
- AUTO I.D.® Sm/RNP Autoantibody - 60 Test System (72 wells) FDA UDI
- Model / Reference
- 6060 FDA UDI
- Description
- AUTO I.D.® Sm/RNP Autoantibody - 60 Test System (72 wells) FDA UDI
Identifiers
- Catalog Number
- 6060 FDA UDI
- Primary DI / UDI-DI
- M7490060601 FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion 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
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 antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion.
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 ac1cce01-9476-47c2-89f9-eda391d09792 34 fields · synced May 31, 2026