Identity
- Trade Name
- IMMUNO-TROL FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control FDA UDI
- Device Name
- Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid – Level 2 DNA* , Anti-ribosomal antigen Ribo , Anti-centromere antigen CENP-B , Anti-histidyl tRNA synthetase antigen Jo-1 , Anti-scleroderma antigen - 70 kDA Scl-70 . FDA UDI
- Model / Reference
- CONNECTIVE 2 FDA UDI
- Description
- Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid – Level 2 DNA* , Anti-ribosomal antigen Ribo , Anti-centromere antigen CENP-B , Anti-histidyl tRNA synthetase antigen Jo-1 , Anti-scleroderma antigen - 70 kDA Scl-70 . FDA UDI
Identifiers
- Catalog Number
- HM 061US-2X05 FDA UDI
- Primary DI / UDI-DI
- 03760170782034 FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening 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
Yes
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, control
Immuno-Trol by Theradiag Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control.
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 e3590496-d50d-4c84-b9e7-f717ee893072 36 fields · synced Jun 8, 2026