Identity
- Trade Name
- HistoCore SPECTRA ST EUDAMEDFDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- HistoCore SPECTRA ST EUDAMEDThe HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. FDA UDI
- Model / Reference
- 14051254354 EUDAMED000000014051254354 FDA UDI
- Description
- The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. FDA UDI
Identifiers
- Catalog Number
- 14051254354 FDA UDI
- Primary DI / UDI-DI
- 04049188191953 EUDAMEDFDA UDI
- Basic UDI-DI
- 010404918805129G EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
HistoCore SPECTRA ST by Leica Biosystems Nussloch Gmbh — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 010404918805129G | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
- EUDAMED SRN
- DE-MF-000021943
Sources (2)
- EUDAMED 845f132f-b898-4c25-be51-6725a50bdd9e 61 fields · synced Jun 17, 2026
- FDA UDI 03b7e5e6-c5a7-4de2-bdef-504a960d50d2 37 fields · synced May 30, 2026