Identity
- Trade Name
- Calibrator Diluent FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Device Name
- Calibrator Diluent FDA UDI
- Model / Reference
- 220-0119 FDA UDI
- Description
- Calibrator Diluent FDA UDI
Identifiers
- Catalog Number
- 2200119 FDA UDI
- Primary DI / UDI-DI
- 00847817003363 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
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
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, calibrator
Calibrator Diluent by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, calibrator.
- Diazyme — Diazyme Laboratories, Inc.
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- HbA1C CAL — Randox Laboratories, Ltd. · Class II
- Chemistry HbA1c Calibrator Kit — Medica Corp. · Class II
- Trinity Biotech — Primus Corp. · Class II
- HbA1c II CALIBRATOR SET (HbA1c II CAL) — Randox Laboratories, Ltd. · Class II
- Direct Glycohemoglobin (HbA1c) Calibrator Set — STANBIO LABORATORY, L.P. · 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI fe84d064-c7fd-466c-84a1-75b5610b35c6 36 fields · synced Jun 1, 2026