Identity
- Trade Name
- IP ActivFlo Biopsy I, Taped, Lilac EUDAMEDLeica Biosystems FDA UDI
- Generic Name
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
- Device Name
- Cassettes EUDAMEDIP ActivFlo Biopsy I, Taped, Lilac FDA UDI
- Model / Reference
- 39LC-605-5-L EUDAMEDFDA UDI
- Description
- IP ActivFlo Biopsy I, Taped, Lilac FDA UDI
Identifiers
- Catalog Number
- 39LC-605-5-L FDA UDI
- Primary DI / UDI-DI
- 10849832021503 EUDAMED20849832021500 FDA UDI
- Basic UDI-DI
- 849832002UH EUDAMED
- Unit of Use DI
- 00849832021506 EUDAMED
- FDA Product Code
- IDZ FDA UDI
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
- GMDN Term
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Histology tissue cassette IVD, laboratory processing, single-use
Leica Biosystems by Leica Biosystems Richmond, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Richmond, Inc.
Sources (2)
- FDA UDI 308915af-f849-4d85-95a9-7c9ec76e1f4a 37 fields · synced Sep 30, 2026
- EUDAMED 457cfa07-90cb-4945-8149-f8ea52100b11 61 fields · synced Sep 30, 2026