Identity
- Trade Name
- Leica ST5020 Config.2 FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The Stainer Leica ST5020 is an automated stain-er for the preparation of histological and cyto-logical routine stainings. It is designed for use in pathology laboratories, and only for performing the following tasks: • Staining of thin sections of tissue specimens or of cytological samples, attached to micro-scope slides • The instrument may be operated only ac¬cording to the instructions contained in this manual. FDA UDI
- Model / Reference
- 14905020EU1 FDA UDI
- Description
- The Stainer Leica ST5020 is an automated stain-er for the preparation of histological and cyto-logical routine stainings. It is designed for use in pathology laboratories, and only for performing the following tasks: • Staining of thin sections of tissue specimens or of cytological samples, attached to micro-scope slides • The instrument may be operated only ac¬cording to the instructions contained in this manual. FDA UDI
Identifiers
- Catalog Number
- 14905020EU1 FDA UDI
- Primary DI / UDI-DI
- 04049188003140 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide 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
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microscope slide stainer IVD
Leica ST5020 Config.2 by Leica Biosystems Nussloch GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Leica Biosystems Nussloch GmbH
Sources (1)
- FDA UDI eeeb5fb5-1f7d-423d-888b-b94fbbb2aa58 37 fields · synced Jun 1, 2026