Identity
- Trade Name
- Atellica IM aCCP QC FDA UDI
- Generic Name
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, control FDA UDI
- Device Name
- anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL FDA UDI
- Model / Reference
- 10732999 FDA UDI
- Description
- anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL FDA UDI
Identifiers
- Catalog Number
- 10732999 FDA UDI
- Primary DI / UDI-DI
- 00630414245676 FDA UDI
- 510(k) Number
- K153551 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
Atellica IM aCCP QC by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, control.
- IMMUNO-TROL — THERADIAG SA
- Alinity — Abbott · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- 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
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- Atellica IM aCCP MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 380a37cf-7ba6-4071-a409-d17b0a632a6a 37 fields · synced Jun 1, 2026