Identity
- Trade Name
- BD FACSuite FDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- Module Assay SCE FACSLyric US IVD FDA UDI
- Model / Reference
- 665006 FDA UDI
- Description
- Module Assay SCE FACSLyric US IVD FDA UDI
Identifiers
- Catalog Number
- 665006 FDA UDI
- Primary DI / UDI-DI
- 00382906650061 FDA UDI
- FDA Product Code
- OYE FDA UDI
- GMDN Term
- White blood cell count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: White blood cell count IVD, kit, cell count
BD FACSuite by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as White blood cell count IVD, kit, cell count.
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- ADVIA® 560 5P Diff 1L — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class I
- Beckman coulter — Immunotech Corp. · Class I
- ADVIA 120/2120/2120i® DIFF TIMEpac — Siemens Healthcare Diagnostics · Class II
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- Leucoscreen Plus Test Kit — Vitrolife AB
- BD Leucocount — BECTON DICKINSON AND COMPANY · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 5021ab6f-1acd-4b34-b3e6-df7fed53ff1f 36 fields · synced May 30, 2026