Identity
- Trade Name
- Pointe autoHDL Cholesterol Reagent FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe autoHDL Cholesterol Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 20ml R2. For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BA-800M analyzer. For in vitro diagnostic use only. Rx Only. FDA UDI
- Model / Reference
- 16-H7545-320 FDA UDI
- Description
- Pointe autoHDL Cholesterol Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 20ml R2. For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BA-800M analyzer. For in vitro diagnostic use only. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 16-H7545-320 FDA UDI
- Primary DI / UDI-DI
- 00811727016171 FDA UDI
- 510(k) Number
- K992002 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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: High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Pointe autoHDL Cholesterol Reagent by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K992002 also covers:
- Pointe Scientific — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. autoHDL Cholesterol — POINTE SCIENTIFIC, INC.
- Pointe autoHDL for the BS480 — POINTE SCIENTIFIC, INC.
- autoHDL — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 485561fd-093d-44eb-866d-db70e0a8c974 37 fields · synced Jun 8, 2026