Identity
- Trade Name
- ADVIA Centaur® ThCG FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- HCG Total - CENTAUR - RGT - 50 tests FDA UDI
- Model / Reference
- 10308985 FDA UDI
- Description
- HCG Total - CENTAUR - RGT - 50 tests FDA UDI
Identifiers
- Catalog Number
- 643953 FDA UDI
- Primary DI / UDI-DI
- 00630414505176 FDA UDI
- 510(k) Number
- K925277 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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: Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® ThCG by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
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- Elecsys HCG Test System — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- iFlash-HCG — Shenzhen YHLO Biotech Co., Ltd. · Class II
- Elecsys HCG STAT Test System — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K925277 also covers:
- ADVIA Centaur® ACS:180® DIL ThCG — Siemens Healthcare Diagnostics
- ADVIA Centaur® ThCG — Siemens Healthcare Diagnostics
- ADVIA Centaur® ThCG DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® ThCG Diluent — Siemens Healthcare Diagnostics
- ADVIA Centaur® ThCG MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Total hCG (ThCG) — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5eb7257a-02d2-4451-8ad4-7a744a129827 37 fields · synced Jun 8, 2026