Identity
- Trade Name
- Atellica IM HCY FDA UDI
- Generic Name
- Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Homocysteine (HYC) Atellica IM - RGT 500T FDA UDI
- Model / Reference
- 10995607 FDA UDI
- Description
- Homocysteine (HYC) Atellica IM - RGT 500T FDA UDI
Identifiers
- Catalog Number
- 10995607 FDA UDI
- Primary DI / UDI-DI
- 00630414599304 FDA UDI
- 510(k) Number
- K013406 FDA UDI
- FDA Product Code
- LPS FDA UDI
- GMDN Term
- Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1377 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: Homocysteine IVD, kit, chemiluminescent immunoassay
Atellica IM HCY by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, kit, chemiluminescent immunoassay.
- ARCHITECT — Abbott · Class II
- IMMULITE® 2000 Systems HCY Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Alinity — Abbott · Class II
- Atellica IM HCY — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® HCY — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K013406 also covers:
- ADVIA Centaur® HCY — Siemens Healthcare Diagnostics
- ADVIA Centaur® HCY DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® HCY MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator — Siemens Healthcare Diagnostics
- Atellica IM HCY — Siemens Healthcare Diagnostics
- Atellica IM HCY Calibrator — Siemens Healthcare Diagnostics
- Atellica IM HCY DIL — Siemens Healthcare Diagnostics
- Atellica IM HCY MCM — 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 29d56e63-5a91-4508-9493-5089eceec693 37 fields · synced Jun 1, 2026