Identity
- Trade Name
- ABX MICROS 60 OS FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- ABX MICROS 60 (O.S.B.) FDA UDI
- Model / Reference
- 1280070105, 1280070106 FDA UDI
- Description
- ABX MICROS 60 (O.S.B.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006160 FDA UDI
- 510(k) Number
- K030799 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haematological cell analyser IVD
Abx Micros 60 Os by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K030799 also covers:
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
- Horiba Abx
Sources (1)
- FDA UDI eb1b5349-1a05-47f2-bb56-1f9ff2e0ec82 34 fields · synced May 31, 2026