Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, calibrator FDA UDI
- Device Name
- BioPlex 2200 25-OH Vitamin D Calibrator Lot Data FDA UDI
- Model / Reference
- 12006553 FDA UDI
- Description
- BioPlex 2200 25-OH Vitamin D Calibrator Lot Data FDA UDI
Identifiers
- Catalog Number
- 12006553 FDA UDI
- Primary DI / UDI-DI
- 03610521185949 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple form 25-hydroxy Vitamin D IVD, calibrator
BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, calibrator.
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- Serum Calibrator Set — Chromsystems Instruments & Chemicals GmbH · Class II
- ADVIA Centaur® Systems VitD Calibrator — Siemens Healthcare Diagnostics · Class II
- Serum Calibration Standard — Chromsystems Instruments & Chemicals GmbH · Class II
- Diazyme — Diazyme Laboratories, Inc.
- IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers — Immunodiagnostic Systems , Ltd. · Class I
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 7b423c5a-3592-4bc0-a949-7f5c5a25a855 37 fields · synced Jun 8, 2026