Identity
- Trade Name
- ADVIA Centaur® Systems, ACS 180® Systems AFP MCM FDA UDI
- Generic Name
- Alpha-fetoprotein (AFP) IVD, control FDA UDI
- Device Name
- Alpha-Fetoprotein (AFP) Master Curve Material Kit FDA UDI
- Model / Reference
- 10311625 FDA UDI
- Description
- Alpha-Fetoprotein (AFP) Master Curve Material Kit FDA UDI
Identifiers
- Catalog Number
- 672428000 FDA UDI
- Primary DI / UDI-DI
- 00630414126319 FDA UDI
- PMA Number
- P930036 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Alpha-fetoprotein (AFP) 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
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: Alpha-fetoprotein (AFP) IVD, control
ADVIA Centaur® Systems, ACS 180® Systems AFP MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-fetoprotein (AFP) IVD, control.
- Alpha-Fetoprotein Control Slides — BIO SB, INC. · Class I
- IMMULITE® Systems AFP Calibration Verification Material — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Alpha-Fetoprotein Control Slides — BIO SB, INC. · Class I
- Alpha-Fetoprotein control slides — BIO SB, INC. · Class I
- ARCHITECT — Abbott Ireland Diagnostics · Class III
- Alinity — Abbott Ireland Diagnostics · Class III
- AIA-PACK AFP Calibration Verification Test Set — Tosoh Corp. · Class I
- Atellica IM AFP MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
P930036 also covers:
- ADVIA Centaur® AFP — Siemens Healthcare Diagnostics
- ADVIA Centaur® Calibrator D — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator D — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator D — Siemens Healthcare Diagnostics
- Atellica IM AFP — Siemens Healthcare Diagnostics
- Atellica IM AFP — Siemens Healthcare Diagnostics
- Atellica IM AFP MCM — Siemens Healthcare Diagnostics
- Atellica IM Calibrator D — Siemens Healthcare Diagnostics
- Atellica IM Calibrator D — Siemens Healthcare Diagnostics
- Atellica IM Calibrator D — Siemens Healthcare Diagnostics
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 11000863-dfad-4f7d-92b5-a253b473a118 37 fields · synced May 30, 2026