Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Microscope slide maker/stainer IVD FDA UDI
- Device Name
- Alinity hs SLIDE MAKER STAINER MODULE FDA UDI
- Model / Reference
- 09P6901 FDA UDI
- Description
- Alinity hs SLIDE MAKER STAINER MODULE FDA UDI
Identifiers
- Catalog Number
- 09P6901 FDA UDI
- Primary DI / UDI-DI
- 00380740138868 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Alinity by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microscope slide maker/stainer IVD.
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- 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
- ABX SPS EVOLUTION — Horiba Abx · Class I
- ABX SPS EVOLUTION — Horiba Abx · Class I
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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI ef5fb872-1df6-480c-a96c-2cdf860a79a9 35 fields · synced May 30, 2026