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Previ® Color Poly-L-Lysine Slides Dual
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 29562
Identity
- Trade Name
- PREVI® COLOR POLY-L-LYSINE SLIDES DUAL EUDAMEDFDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- PREVI® COLOR POLY-L-LYSINE SLIDES DUAL EUDAMEDPre-coated dual slides with Poly-L-Lysine to be used to reduce cell loss during wet fixation and staining (to be used with dual sample chambers) FDA UDI
- Model / Reference
- 29562 EUDAMEDPREVI® COLOR POLY-L-LYSINE SLIDES DUAL FDA UDI
- Description
- Pre-coated dual slides with Poly-L-Lysine to be used to reduce cell loss during wet fixation and staining (to be used with dual sample chambers) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026227746 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000546TT EUDAMED
- Unit of Use DI
- 03573026615192 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W02039085 VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microscope slide stainer IVD
Previ® Color Poly-L-Lysine Slides Dual by Biomerieux , 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
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 |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 11d97091-bca5-4835-8250-bd1f9267a57a 33 fields · synced Jun 19, 2026
- EUDAMED 01cd2bed-c950-4e67-b8a5-20764a20beac 61 fields · synced Jun 19, 2026