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MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2)
FDA UDIEUDAMEDClass I (US FDA UDI)
by Sebia, Inc.
Identity
- Trade Name
- MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2) FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Model / Reference
- 4767 FDA UDI
Identifiers
- Catalog Number
- 4767 FDA UDI
- Primary DI / UDI-DI
- 03607360047675 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, control
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2) by Sebia, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, control.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- HbA1C CONTROL — Randox Laboratories, Ltd. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- HbA1c — POINTE SCIENTIFIC, INC. · Class II
- MAS Diabetes Max, Multi-pack — Microgenics Corporation · Class I
- PreciControl HbA1c path — Roche Diagnostics Corp. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Liquid Glycated Haemoglobin (HbA1c) Control Level 2 (LIQ HbA1c CONTROL LEVEL 2) — Randox Laboratories, Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sebia, Inc.
Sources (2)
- FDA UDI ae3c9edb-3ec7-48a8-9a48-c118f1f4d173 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026