Identity
- Trade Name
- hemochroma PLUS Control FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, control FDA UDI
- Device Name
- hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS System in measuring the human hemoglobin concentration. FDA UDI
- Model / Reference
- 100-303 FDA UDI
- Description
- hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS System in measuring the human hemoglobin concentration. FDA UDI
Identifiers
- Catalog Number
- 100-303 FDA UDI
- Primary DI / UDI-DI
- 10722355003037 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
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, control
hemochroma PLUS Control by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total haemoglobin (totHb) IVD, control.
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- 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
- Immunostics, Inc.
Sources (1)
- FDA UDI 0b559efa-76af-4b49-b98a-02c4d6e32cb9 36 fields · synced May 30, 2026