Identity
- Trade Name
- Pointe Cholesterol Reagent FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Cholesterol Reagent packaged for use on the Mindray BA800. 8 x 65ml. For the quantitative determination of Total Cholesterol in serum. FDA UDI
- Model / Reference
- 16-C7510-520 FDA UDI
- Description
- Pointe Cholesterol Reagent packaged for use on the Mindray BA800. 8 x 65ml. For the quantitative determination of Total Cholesterol in serum. FDA UDI
Identifiers
- Catalog Number
- 16-C7510-520 FDA UDI
- Primary DI / UDI-DI
- 00811727016089 FDA UDI
- 510(k) Number
- K810673 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 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
No
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: Total cholesterol lipid IVD, kit, spectrophotometry
Pointe Cholesterol Reagent by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 0dfd540b-3225-4e2e-8ef0-bcdd59fc2f11 37 fields · synced May 30, 2026