Identity
- Trade Name
- Pointe Lp(a) Reagent FDA UDI
- Generic Name
- Lipoprotein A IVD, reagent FDA UDI
- Device Name
- Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. FDA UDI
- Model / Reference
- 14-L7597-216 FDA UDI
- Description
- Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. FDA UDI
Identifiers
- Catalog Number
- 14-L7597-216 FDA UDI
- Primary DI / UDI-DI
- 00811727015921 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 Lp(a) Reagent 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 Scientific, Inc. Lipoprotein (a) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II
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 4b460580-f3cf-43c1-88e8-eee2a5a0fb69 36 fields · synced May 30, 2026