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Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FDA UDI
- Generic Name
- Homocysteine IVD, reagent FDA UDI
- Device Name
- The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. FDA UDI
- Model / Reference
- FHRWR100 FDA UDI
- Description
- The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. FDA UDI
Identifiers
- Catalog Number
- FHRWR100 FDA UDI
- Primary DI / UDI-DI
- 05055845400169 FDA UDI
- 510(k) Number
- K083222 FDA UDI
- FDA Product Code
- JIT FDA UDILPS FDA UDI
- GMDN Term
- Homocysteine IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1377 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
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
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit by Axis-Shield Diagnostics Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Homocysteine IVD, reagent.
- Diazyme — Diazyme Laboratories, Inc.
- 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.
- HCY — Randox Laboratories, Ltd. · Class II
- N Latex HCY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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
- Pointe Homocysteine for BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- HCY — Randox Laboratories, 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
- Axis-Shield Diagnostics Limited
Sources (1)
- FDA UDI 9f0cd5a6-17f2-4978-8f6c-953710ec3e5f 37 fields · synced Jun 1, 2026