Identity
- Trade Name
- Pointe Homocysteine for BS480 FDA UDI
- Generic Name
- Homocysteine IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Homocysteine Reagent packaged for use on the BS480 Analyzer. 2x60mL, 2x12mL, w/calibrator kit. The Liquid Stable 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
- 14-H7575-144 FDA UDI
- Description
- Pointe Homocysteine Reagent packaged for use on the BS480 Analyzer. 2x60mL, 2x12mL, w/calibrator kit. The Liquid Stable 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
- 14-H7575-144 FDA UDI
- Primary DI / UDI-DI
- 00811727015877 FDA UDI
- 510(k) Number
- K083222 FDA UDI
- FDA Product Code
- LPS FDA UDI
- GMDN Term
- Homocysteine IVD, kit, spectrophotometry 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
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, kit, spectrophotometry
Pointe Homocysteine for BS480 by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, kit, spectrophotometry.
- Homocysteine Enzymatic Assay — Roche Diagnostics Corp. · Class II
- Homocysteine Enzymatic Assay — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201-300 — Carolina Liquid Chemistries Corp. · Class II
- Homocysteine Enzymatic Assay — Roche Diagnostics Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201 — Carolina Liquid Chemistries Corp. · Class II
- Homocysteine Enzymatic Assay — Roche Diagnostics Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT Product No. ST201 — Carolina Liquid Chemistries Corp. · 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
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit — Axis-Shield Diagnostics Limited
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 6b7aa796-b947-41b4-9e16-e393cfb6ab5b 37 fields · synced Jun 1, 2026