Identity
- Trade Name
- Pointe Scientific, Inc. Triglyceride FDA UDI
- Generic Name
- Triglyceride IVD, reagent FDA UDI
- Device Name
- Pointe Scientific, Inc. Triglyceride Reagent is for the in vitro quantitative determination of Triglycerides in serum or plasma. Packaged for use on Olympus Analyzers. 12 x 65ml FDA UDI
- Model / Reference
- OT932-780 FDA UDI
- Description
- Pointe Scientific, Inc. Triglyceride Reagent is for the in vitro quantitative determination of Triglycerides in serum or plasma. Packaged for use on Olympus Analyzers. 12 x 65ml FDA UDI
Identifiers
- Catalog Number
- OT932-780 FDA UDI
- Primary DI / UDI-DI
- 00811727015129 FDA UDI
- 510(k) Number
- K862033 FDA UDI
- FDA Product Code
- CDT FDA UDI
- GMDN Term
- Triglyceride IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1705 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: Triglyceride IVD, reagent
Pointe Scientific, Inc. Triglyceride by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Triglyceride IVD, reagent.
- Triglycerides – Liquizyme GPO-PAP (Single Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
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- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Triglycerides Kit (GPO-POD Method) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- ΤΡΙΓΛΥΚΕΡΙΔΙΑ LIQUID 8x45 ml (UR8210/PPC300N) — Biotechnological Applications Ltd · IVD General
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- TRIGLYCERIDES — Medicon Hellas SA · Class B
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Cleared under the same submission
K862033 also covers:
- Point 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. Triglycerides — POINTE SCIENTIFIC, INC.
- Pointe Triglyceride Reagent — POINTE SCIENTIFIC, INC.
- Pointe Triglycerides Reagent — POINTE SCIENTIFIC, INC.
- Triglyceride — 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 |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI b46e6bd0-c687-4690-a9e4-4c8889a4b40f 37 fields · synced May 30, 2026