Identity
- Trade Name
- IMMUNO-TROL FDA UDI
- Generic Name
- Cyclic citrullinated peptide antibody (anti-CCP) 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: human and animal anti-Rheumatoid Factors IgM isotype (RF (H&A) IgM) , anti-cyclic citrullinated peptide IgG isotype (CCP IgG ). FDA UDI
- Model / Reference
- RHEUMA FDA UDI
- Description
- Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: human and animal anti-Rheumatoid Factors IgM isotype (RF (H&A) IgM) , anti-cyclic citrullinated peptide IgG isotype (CCP IgG ). FDA UDI
Identifiers
- Catalog Number
- HM 064US-2X05 FDA UDI
- Primary DI / UDI-DI
- 03760170782065 FDA UDI
- GMDN Term
- Cyclic citrullinated peptide antibody (anti-CCP) 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: Rheumatoid factor IVD, controlCyclic citrullinated peptide antibody (anti-CCP) IVD, control
Immuno-Trol by Theradiag Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, control.
- Alinity — Abbott · Class I
- Atellica IM aCCP MCM — Siemens Healthcare Diagnostics · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- Atellica IM aCCP QC — Siemens Healthcare Diagnostics · Class I
- IMMULITE 2000 Systems Anti-CCP IgG Calibration Verification Material — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- ARCHITECT — Abbott · Class II
- ADVIA Centaur® aCCP IgG QC — Siemens Healthcare Diagnostics · Class I
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 ca97a694-83d3-4747-975b-06f46f40ed1d 36 fields · synced Jun 6, 2026