Identity
- Trade Name
- FIDIS FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex FDA UDI
- Device Name
- Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes FDA UDI
- Model / Reference
- Connective 10 FDA UDI
- Description
- Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes FDA UDI
Identifiers
- Catalog Number
- MX 506 FDA UDI
- Primary DI / UDI-DI
- 03760170782003 FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex 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
No
FDA UDI
Category: Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
Fidis by Theradiag Sa — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Theradiag Sa
Sources (1)
- FDA UDI b671180f-0028-436c-a0a7-dbc9cd3dbedb 36 fields · synced May 30, 2026