Identity
- Trade Name
- VIDAS® 3 ASSAY DILUTION CUP EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- VIDAS® 3 ASSAY DILUTION CUP EUDAMEDThe VIDAS®3 can perform dilutions and manage two dilution cup racks holding 16 cups each. FDA UDI
- Model / Reference
- 542653 EUDAMEDVIDAS® 3 ASSAY DILUTION CUP FDA UDI
- Description
- The VIDAS®3 can perform dilutions and manage two dilution cup racks holding 16 cups each. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026612849 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000296TT EUDAMED
- 510(k) Number
- K141133 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Fluorescent immunoassay analyser IVD, laboratory
Vidas® 3 Assay Dilution Cup by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescent immunoassay analyser IVD, laboratory.
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Cleared under the same submission
K141133 also covers:
- VIDAS 3 — BIOMERIEUX , INC.
- VIDAS 3 — BIOMERIEUX , INC.
- VIDAS® 3 — BIOMERIEUX , INC.
- VIDAS® 3 SOFTWARE V1.4 — BIOMERIEUX , INC.
- VIDAS® D-Dimer Exclusion II ™ — BIOMERIEUX , INC.
- VIDAS® H. pylori IgG — BIOMERIEUX , INC.
- VIDAS® HCG — BIOMERIEUX , INC.
- VIDAS® RUB IgG — BIOMERIEUX , INC.
- VIDAS® Refurbished — BIOMERIEUX , INC.
- VIDAS® TOXO IgM — BIOMERIEUX , INC.
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 124b1ee7-0a9c-46f5-be6c-04cfd0aacb9f 34 fields · synced Jun 19, 2026
- EUDAMED 7aeec12f-e5d0-48ed-a377-2255629f6414 61 fields · synced Jun 19, 2026