Identity
- Trade Name
- Pointe Scientific, Inc. Lipoprotein (a) FDA UDI
- Generic Name
- Lipoprotein A IVD, reagent FDA UDI
- Device Name
- Pointe Scientific, Inc. Lipoprotein (a) Reagent is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. 1 x 30 ml, 1 x 10 ml FDA UDI
- Model / Reference
- L7597-40 FDA UDI
- Description
- Pointe Scientific, Inc. Lipoprotein (a) Reagent is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. 1 x 30 ml, 1 x 10 ml FDA UDI
Identifiers
- Catalog Number
- L7597-40 FDA UDI
- Primary DI / UDI-DI
- 00811727011824 FDA UDI
- 510(k) Number
- K013359 FDA UDI
- FDA Product Code
- DFC FDA UDI
- GMDN Term
- Lipoprotein A IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5600 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: Lipoprotein A IVD, reagent
Pointe Scientific, Inc. Lipoprotein (a) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lipoprotein A IVD, reagent.
- K-ASSAY® Lp(a) Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Lp(a) Ultra — Sentinel Ch. Srl · Class II
- Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II
- Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K013359 also covers:
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI d761f96b-2f37-4ce3-b2f4-439c93320c4b 37 fields · synced Jun 1, 2026