Identity
- Trade Name
- Carrier Box, ETC, Slide, IVD FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
- Model / Reference
- 800-20301 FDA UDI
Identifiers
- Catalog Number
- 800-20301 FDA UDI
- Primary DI / UDI-DI
- 10888234102670 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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: Optical laboratory instrument performance standard calibrator/control IVD, reusable
Carrier Box, ETC, Slide, IVD by Bioarray Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical laboratory instrument performance standard calibrator/control IVD, reusable.
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- DensiCHEK™ CALIBRATION STANDARD — BIOMERIEUX , INC. · Class II
- Simplexa™ Spectral Calibration Panel — DiaSorin Molecular LLC
- Cholestech LDX™ — Alere San Diego, Inc. · Class I
Cleared under the same submission
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
- Bioarray Solutions Ltd
Sources (1)
- FDA UDI d8fde59d-e0e1-4293-b117-ac4aea47d355 35 fields · synced Jun 8, 2026