Identity
- Trade Name
- Pointe Total Protein Reagent FDA UDI
- Generic Name
- Total protein IVD, reagent FDA UDI
- Device Name
- Pointe Total Protein Reagent packaged for use on the Mindray BS480. 8 x 60ml. For the quantitative determination of total protein concentration in serum. FDA UDI
- Model / Reference
- 14-T7528-480 FDA UDI
- Description
- Pointe Total Protein Reagent packaged for use on the Mindray BS480. 8 x 60ml. For the quantitative determination of total protein concentration in serum. FDA UDI
Identifiers
- Catalog Number
- 14-T7528-480 FDA UDI
- Primary DI / UDI-DI
- 00811727015976 FDA UDI
- 510(k) Number
- K822468 FDA UDI
- FDA Product Code
- CEK FDA UDI
- GMDN Term
- Total protein IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1635 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: Total protein IVD, reagent
Pointe Total Protein Reagent by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K822468 also covers:
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Protein — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Protein — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Protein — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Protein — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Protein — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Protein — POINTE SCIENTIFIC, INC.
- Pointe Total Protein Reagent — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 9963fc99-71e1-4d11-bde7-66c1303e96f2 37 fields · synced May 30, 2026