Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Hemoglobin Reagent, for the quantitative determination of Hemoglobin in whole blood. Size: 1 x 500 mL FDA UDI
- Model / Reference
- H7504-500 FDA UDI
- Description
- Hemoglobin Reagent, for the quantitative determination of Hemoglobin in whole blood. Size: 1 x 500 mL FDA UDI
Identifiers
- Catalog Number
- H7504-500 FDA UDI
- Primary DI / UDI-DI
- 00811727014528 FDA UDI
- 510(k) Number
- K851432 FDA UDI
- FDA Product Code
- KHG FDA UDI
- GMDN Term
- Total haemoglobin (totHb) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7500 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 haemoglobin (totHb) IVD, kit, spectrophotometry
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total haemoglobin (totHb) IVD, kit, spectrophotometry.
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- Glycohemoglobin Pre-Fil — STANBIO LABORATORY, L.P. · Class II
- Glycohemoglobin — STANBIO LABORATORY, L.P. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI a7e35584-67b8-40c1-9b76-c7a3ad21e084 37 fields · synced Jun 8, 2026