Identity
- Trade Name
- Pointe Scientfic, Inc. Lipid Controls FDA UDI
- Generic Name
- Multiple lipid analyte IVD, control FDA UDI
- Device Name
- Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens. 6 x 3 ml. FDA UDI
- Model / Reference
- L7580-18 FDA UDI
- Description
- Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens. 6 x 3 ml. FDA UDI
Identifiers
- Catalog Number
- L7580-18 FDA UDI
- Primary DI / UDI-DI
- 00811727011848 FDA UDI
- 510(k) Number
- K951749 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Multiple lipid analyte IVD, control
Pointe Scientfic, Inc. Lipid Controls by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple lipid analyte IVD, control.
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- Diazyme — Diazyme Laboratories, Inc.
- LIQUID QC LIPID CONTROL LEVEL 2 — CLINIQA CORPORATION · Class I
- LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1) — Randox Laboratories, Ltd. · Class I
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 676ae66a-241c-495c-b46d-80667161faa5 37 fields · synced Jun 8, 2026