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Leica Biosystems HIGH TRANSM. DUAL O/G FOR LEICA DM
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Leica Biosystems HIGH TRANSM. DUAL O/G FOR LEICA DM FDA UDI
- Generic Name
- Fluorescence light microscope FDA UDI
- Device Name
- Leica Biosystems HIGH TRANSM. DUAL O/G FOR LEICA DM FDA UDI
- Model / Reference
- 232FLAL325272 FDA UDI
- Description
- Leica Biosystems HIGH TRANSM. DUAL O/G FOR LEICA DM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849832011484 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. DUAL O/G 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 be85d436-6cb9-4cef-a0b5-e79b9070506c 38 fields · synced May 30, 2026