Identity
- Trade Name
- VIDAS® H. pylori IgG FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA). FDA UDI
- Model / Reference
- 30192-01 FDA UDI
- Description
- VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026509231 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3110 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS® H. pylori IgG by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- ELISA H. pylori IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Status™ H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
- BioSign® H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
- GAP®-IgG (Gastritis and Peptic Ulcer Test) — BIOMERICA, INC. · Class I
- BioSign® H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
Cleared under the same submission
K141133 also covers:
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- VIDAS 3 — BIOMERIEUX , INC.
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- VIDAS® HCG — BIOMERIEUX , INC.
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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 ae71b97d-ca7a-45b6-80c0-7f82cad4bbe2 35 fields · synced May 30, 2026