Identity
- Trade Name
- Atellica CH hsCRP Calibrator FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, calibrator FDA UDI
- Device Name
- High Sensitivity C-Reative Protein (hsCRP) Calibrator Atellica CH - CAS 5 x 1 x 1.0mL FDA UDI
- Model / Reference
- 11099412 FDA UDI
- Description
- High Sensitivity C-Reative Protein (hsCRP) Calibrator Atellica CH - CAS 5 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 11099412 FDA UDI
- Primary DI / UDI-DI
- 00630414597508 FDA UDI
- 510(k) Number
- K081294 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
FDA UDI
Category: C-reactive protein (CRP) IVD, calibrator
Atellica CH hsCRP Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, calibrator.
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- POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L) — POINTE SCIENTIFIC, INC. · Class II
- CRP CAL — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- hsCRP CAL — Randox Laboratories, Ltd. · Class II
- POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L) — POINTE SCIENTIFIC, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 7dd3c1c5-9b76-47ce-9547-94eace704b42 37 fields · synced May 30, 2026