Identity
- Trade Name
- Leica TP1020 F /accessories 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 processing speci-mens—provided that it is operated according to these Instructions for Use. The Leica TP1020 is a modular automated tissue processor designed for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica TP1020 must be operated exclusively with the reagents listed in the IFU FDA UDI
- Model / Reference
- 1491020US01 FDA UDI
- Description
- The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that it is operated according to these Instructions for Use. The Leica TP1020 is a modular automated tissue processor designed for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica TP1020 must be operated exclusively with the reagents listed in the IFU FDA UDI
Identifiers
- Catalog Number
- 1491020US01 FDA UDI
- Primary DI / UDI-DI
- 04049188003119 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 TP1020 F /accessories by Leica Biosystems Nussloch GmbH — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tissue processor IVD, automated/semi-automated.
- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
- Tissue-Tek Xpress® — Sakura Finetek USA, Inc · Class I
- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
- Tissue-Tek VIP® 6 — Sakura Finetek USA, Inc · Class I
- HistoCore PELORIS — LEICA BIOSYSTEMS MELBOURNE PTY LTD · Class I
- VP2000 — Abbott Molecular · Class I
- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
Sources (2)
- FDA UDI 650bd5de-4b17-498f-acda-464621d65acc 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026