Identity
- Trade Name
- HCY FDA UDI
- Generic Name
- Homocysteine IVD, reagent FDA UDI
- Device Name
- A homocysteine test system is a device intended for the quantitative in vitro determination of homocysteine concentration in human serum. FDA UDI
- Model / Reference
- HY4036 FDA UDI
- Description
- A homocysteine test system is a device intended for the quantitative in vitro determination of homocysteine concentration in human serum. FDA UDI
Identifiers
- Catalog Number
- HY4036 FDA UDI
- Primary DI / UDI-DI
- 05055273208894 FDA UDI
- 510(k) Number
- K083222 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Hcy by Randox Laboratories, 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.
- DImension Vista® Homocysteine Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K083222 also covers:
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent — Axis-Shield Diagnostics Limited
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit — Axis-Shield Diagnostics Limited
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit — Axis-Shield Diagnostics Limited
- Pointe Homocysteine for BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI cf939a6c-6b55-4788-93dd-28f3d1615764 37 fields · synced May 31, 2026