Identity
- Trade Name
- Leica ASP300 S - China FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- The instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. FDA UDI
- Model / Reference
- 000000014047643057 FDA UDI
- Description
- The instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. FDA UDI
Identifiers
- Catalog Number
- 14047643057 FDA UDI
- Primary DI / UDI-DI
- 04049188056146 FDA UDI
- FDA Product Code
- IEO FDA UDI
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3875 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: Tissue processor IVD, automated/semi-automated
Leica ASP300 S - China 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 781e7fee-fcc6-4c39-88ce-6f4137527616 37 fields · synced Jun 8, 2026