Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, kit, spectrophotometry FDA UDI
- Device Name
- One Step + HB Starter Kit FDA UDI
- Model / Reference
- 5701314 FDA UDI
- Description
- One Step + HB Starter Kit FDA UDI
Identifiers
- Catalog Number
- 5701314 FDA UDI
- Primary DI / UDI-DI
- 00304040103814 FDA UDI
- FDA Product Code
- GKR FDA UDI
- GMDN Term
- Total haemoglobin (totHb) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5620 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total haemoglobin (totHb) IVD, controlTotal haemoglobin (totHb) IVD, kit, spectrophotometryTotal haemoglobin (totHb) IVD, reagent
Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total haemoglobin (totHb) IVD, reagent.
- SULFOLYSER — Sysmex Corp. · Class I
- SULFOLYSER — Sysmex Corp. · Class I
- hemochroma PLUS Microcuvettes — IMMUNOSTICS, INC. · Class II
- Teco Diagnostics Hemoglobin Reagent Set — TECO DIAGNOSTICS · Class II
- hemochroma PLUS Starter Kit — IMMUNOSTICS, INC. · Class II
- Teco Diagnostics Hemoglobin Reagent Set — TECO DIAGNOSTICS · Class II
- Henry Schein — HENRY SCHEIN, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (1)
- FDA UDI c64482ec-c412-45c2-8f96-3227536c4e1d 35 fields · synced May 30, 2026