Identity
- Trade Name
- VIDAS 3 FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- VIDAS 3 V1.3.2 PATCH FDA UDI
- Model / Reference
- 1.3.2 FDA UDI
- Description
- VIDAS 3 V1.3.2 PATCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026613839 FDA UDI
- 510(k) Number
- K141133 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Commercial Distribution
- 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
Category: Fluorescent immunoassay analyser IVD, laboratory
Vidas 3 by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 ASSAY DILUTION CUP — 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 (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 I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI b5d9781b-d1e5-4a88-8a3d-f18b9fdf0e72 34 fields · synced Jun 8, 2026