Previ® Color Dual Sample Chambers Fast (white)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE) EUDAMEDFDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE) EUDAMEDThe chamber features a sample loading system that places a spot on the microscope slide. FDA UDI
- Model / Reference
- 29560 EUDAMEDPREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE) FDA UDI
- Description
- The chamber features a sample loading system that places a spot on the microscope slide. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026227722 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000510T6 EUDAMED
- Unit of Use DI
- 03573026615178 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
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
Yes
Manufacturing Date
No
Category: Microscope slide stainer IVD
Previ® Color Dual Sample Chambers Fast (white) 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
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
- Biomerieux , Inc.
Sources (2)
- FDA UDI da306cd2-cb7f-4c6d-a4ac-c4e5bf81a91e 33 fields · synced Oct 6, 2026
- EUDAMED 0ef0d114-a69a-4ad1-ac11-7c66e0d8bab4 61 fields · synced Jul 23, 2026