Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. 1 x 240ml, 1 x 80ml FDA UDI
- Model / Reference
- L7574-320 FDA UDI
- Description
- Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. 1 x 240ml, 1 x 80ml FDA UDI
Identifiers
- Catalog Number
- L7574-320 FDA UDI
- Primary DI / UDI-DI
- 00811727011787 FDA UDI
- 510(k) Number
- K981978 FDA UDI
- FDA Product Code
- MRR FDA UDI
- GMDN Term
- Low density lipoprotein (LDL) 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: Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry.
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Cleared under the same submission
K981978 also covers:
- Pointe Scientific autoLDL Cholesterol — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. autoLDL Cholesterol — POINTE SCIENTIFIC, INC.
- Pointe autoLDL Cholesterol Reagent — POINTE SCIENTIFIC, INC.
- Pointe autoLDL Cholesterol Reagent — POINTE SCIENTIFIC, INC.
- autoLDL — 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 28d1e031-053e-4aed-beba-6f81460a7e62 37 fields · synced May 30, 2026