Identity
- Trade Name
- IMMULITE® 2000 Systems CCP Anti-CCP IgG FDA UDI
- Generic Name
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- CCP IgG Ab - IMMULITE - RGT - 200 Tests FDA UDI
- Model / Reference
- 10718148 FDA UDI
- Description
- CCP IgG Ab - IMMULITE - RGT - 200 Tests FDA UDI
Identifiers
- Catalog Number
- L2KPI2(D) FDA UDI
- Primary DI / UDI-DI
- 00630414601991 FDA UDI
- 510(k) Number
- K121576 FDA UDI
- FDA Product Code
- NHX FDA UDI
- GMDN Term
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 FDA UDI
- 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
No
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: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems CCP Anti-CCP IgG by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay.
- ADVIA Centaur® aCCP IgG — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott · Class II
- Atellica IM aCCP — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI cbb15260-0dd8-4994-af4d-2cb754495384 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026