Identity
- Trade Name
- N Latex HCY FDA UDI
- Generic Name
- Homocysteine IVD, reagent FDA UDI
- Device Name
- Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems FDA UDI
- Model / Reference
- 10445973 FDA UDI
- Description
- Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems FDA UDI
Identifiers
- Catalog Number
- OPAX03 FDA UDI
- Primary DI / UDI-DI
- 00842768006715 FDA UDI
- 510(k) Number
- K052788 FDA UDI
- FDA Product Code
- LPS FDA UDI
- GMDN Term
- Homocysteine IVD, reagent 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, reagent
N Latex HCY by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, reagent.
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit — Axis-Shield Diagnostics Limited
- Diazyme — Diazyme Laboratories, Inc.
- 3-Reagent Homocysteine Assay for SYNCHRON UniCel — Axis-Shield Diagnostics Limited · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- HCY — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K052788 also covers:
- N Protein Standard SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Protein Standard SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N/T Protein Control SL/H — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N/T Protein Control SL/L — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N/T Protein Control SL/M — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI b7f2fe99-6b93-4478-8b71-61e5279395a7 37 fields · synced Jun 8, 2026