Identity
- Trade Name
- ADVIA Centaur® LH FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Lutenizing Hormone (Ref) - CENTAUR - RGT - 300 tests FDA UDI
- Model / Reference
- 10332181 FDA UDI
- Description
- Lutenizing Hormone (Ref) - CENTAUR - RGT - 300 tests FDA UDI
Identifiers
- Catalog Number
- 118826 FDA UDI
- Primary DI / UDI-DI
- 00630414204628 FDA UDI
- 510(k) Number
- K910198 FDA UDI
- FDA Product Code
- CEP FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 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: Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® LH by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay.
- Alinity — ABBOTT IRELAND · Class I
- Elecsys LH — Roche Diagnostics Corp. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- Alinity — ABBOTT IRELAND · Class I
- IMMULITE® 2000 Systems LH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- iFlash-LH — Shenzhen YHLO Biotech Co., Ltd. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- IMMULITE 2000 LH Kit Domestic 200T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| 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 (2)
- FDA UDI 9f3eed89-e61b-45a2-b502-23f8e0631309 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026