Identity
- Trade Name
- Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM FDA UDI
- Generic Name
- Fluorescence light microscope FDA UDI
- Device Name
- Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM FDA UDI
- Model / Reference
- 232FLAL311972 FDA UDI
- Description
- Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849832011446 FDA UDI
- 510(k) Number
- K042542 FDA UDI
- FDA Product Code
- JOY FDA UDI
- GMDN Term
- Fluorescence light microscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM by Leica Biosystems Richmond, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K042542 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Richmond, Inc.
Sources (1)
- FDA UDI b40bc2da-ce68-409f-b65b-b9aa9466eca0 38 fields · synced May 29, 2026