Identity
- Trade Name
- ADVIA Centaur® FSH MCM FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, control FDA UDI
- Device Name
- Follicular Stimulating Hormone Master Curve Material Set - CENTAUR - CONS FDA UDI
- Model / Reference
- 10311617 FDA UDI
- Description
- Follicular Stimulating Hormone Master Curve Material Set - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 672418000 FDA UDI
- Primary DI / UDI-DI
- 00630414126210 FDA UDI
- 510(k) Number
- K904649 FDA UDI
- FDA Product Code
- CGJ FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1300 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: Follicle stimulating hormone (FSH) IVD, control
ADVIA Centaur® FSH MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, control.
- FSH Control Slides — BIO SB, INC. · Class I
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- Alinity — ABBOTT IRELAND · Class I
- IMMULITE® Systems FSH Calibration Verification Material FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- FSH Control Slides — BIO SB, INC. · Class I
- FSH Control Slides — BIO SB, INC. · Class I
- AIA-PACK FSH Calibration Verification Test Set — Tosoh Corp. · Class I
- ARCHITECT — ABBOTT IRELAND · 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 28072a62-1eb7-430f-b0a5-9099c2d0d702 37 fields · synced Jun 6, 2026