Identity
- Trade Name
- Atellica IM HCY MCM FDA UDI
- Generic Name
- Homocysteine IVD, control FDA UDI
- Device Name
- Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995609 FDA UDI
- Description
- Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995609 FDA UDI
- Primary DI / UDI-DI
- 00630414599328 FDA UDI
- 510(k) Number
- K013406 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Homocysteine 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
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, control
Atellica IM HCY MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, control.
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 — Carolina Liquid Chemistries Corp. · Class II
- Liquichek — Bio-Rad Laboratories · Class I
- Audit MicroControls Control LQ Homocysteine — Aalto Scientific, Ltd. · Class I
- Plasma Control Bi-Level — Chromsystems Instruments & Chemicals GmbH · Class I
- ARCHITECT — Abbott · Class II
- InteliQ — Bio-Rad Laboratories · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 — Carolina Liquid Chemistries Corp. · Class I
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 — Siemens Healthcare Diagnostics
- Atellica IM HCY Calibrator — Siemens Healthcare Diagnostics
- Atellica IM HCY DIL — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b79d1849-88ed-4bec-8718-57187af732f5 37 fields · synced May 30, 2026