Identity
- Trade Name
- ABX SPS EVOLUTION FDA UDI
- Generic Name
- Microscope slide maker/stainer IVD FDA UDI
- Model / Reference
- 1280160018, 1280160020 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006481 FDA UDI
- 510(k) Number
- K050719 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide maker/stainer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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: Microscope slide maker/stainer IVD
Abx Sps Evolution by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microscope slide maker/stainer IVD.
- Alinity — Abbott Laboratories, Inc. · Class I
- Tissue-Tek Prisma® — Sakura Finetek USA, Inc · Class I
- BD PrepStain Slide Processor — BECTON DICKINSON AND COMPANY · Class III
- ADVIA Autoslide® Slide Maker Stainer — Siemens Healthcare Diagnostics · Class I
- Histo-Tek® SL — Sakura Finetek USA, Inc · Class I
- Tissue-Tek Prisma® Plus — Sakura Finetek USA, Inc · Class I
- ADVIA Autoslide® Slide Maker Stainer — Siemens Healthcare Diagnostics · Class I
- Q-STAIN® X Autostainer — NOVODIAX, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI c390aab9-b4ce-47a6-a1c4-e278e182dafd 33 fields · synced Jun 6, 2026