Identity
- Trade Name
- DiaSpect Control Pack HBT4 FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, control FDA UDI
- Device Name
- For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes FDA UDI
- Model / Reference
- 90B.0014 FDA UDI
- Description
- For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048534001588 FDA UDI
- FDA Product Code
- GGM FDA UDI
- GMDN Term
- Total haemoglobin (totHb) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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 haemoglobin (totHb) IVD, control
DiaSpect Control Pack HBT4 by DiaSpect Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total haemoglobin (totHb) IVD, control.
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- Glycohemoglobin Bi-Level Controls — STANBIO LABORATORY, L.P. · Class II
- Eurotrol — Eurotrol B.V. · Class II
- Direct Glycohemoglobin (HbA1c) Control Set — STANBIO LABORATORY, L.P. · Class II
- Eurotrol — Eurotrol B.V. · Class II
- Eurotrol — Eurotrol B.V. · 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 |
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Manufacturer
- Manufacturer
- DiaSpect Medical GmbH
Sources (1)
- FDA UDI a13d592e-a635-454d-8c37-6dcfef604029 35 fields · synced May 30, 2026