← Back to catalogue
Gold Standard Diagnostics H. pylori ELISA IgG Test Kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics H. pylori ELISA IgG Test Kit FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit FDA UDI
- Model / Reference
- GSD01-1000 FDA UDI
- Description
- Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B350GSD0110000 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
Yes
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)
Gold Standard Diagnostics H. pylori ELISA IgG Test Kit by Gold Standard Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- QUANTA Lite® H.pylori IgG ELISA — INOVA DIAGNOSTICS, INC. · Class I
- Status™ H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
- ELISA H. pylori IgG Test System — ZEUS SCIENTIFIC, INC.
- ELISA H. pylori IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- VIDAS® H. pylori IgG — BIOMERIEUX , INC. · Class I
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 10eb4127-c266-42ed-aaea-f9fe4f6c35dc 34 fields · synced Jun 8, 2026