Identity
- Trade Name
- COULTER AcT FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- COULTER Ac·T diff 2 Analyzer FDA UDI
- Model / Reference
- diff 2 FDA UDI
- Description
- COULTER Ac·T diff 2 Analyzer FDA UDI
Identifiers
- Catalog Number
- 6605500 FDA UDI
- Primary DI / UDI-DI
- 15099590264796 FDA UDI
- 510(k) Number
- K990352 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Haematological cell analyser IVD 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haematological cell analyser IVD
COULTER AcT by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological cell analyser IVD.
- ABX PENTRA DX 120 — Horiba Abx · Class II
- ABX MICROS ES60 CT — Horiba Abx · Class II
- ABX MICROS ES60 OT — Horiba Abx · Class II
- ABX PENTRA DF 120 — Horiba Abx · Class II
- Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays — Advanced Instruments, LLC · Class II
- ADVIA 2120i wthout Autosampler — Siemens Healthcare Diagnostics · Class II
- Medonic M-series — Boule Medical AB · Class II
- Automated Hematology Analyzer XS series XS-1000i — Sysmex Corp. · 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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI fe0f1e59-1dde-4408-bcf6-a50554b921dc 35 fields · synced Jun 6, 2026