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Gold Standard Diagnostics H. pylori ELISA IgA Test Kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics H. pylori ELISA IgA Test Kit FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Gold Standard Diagnostics H. pylori ELISA IgA Test Kit FDA UDI
- Model / Reference
- GSD01-1001 FDA UDI
- Description
- Gold Standard Diagnostics H. pylori ELISA IgA Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B350GSD0110010 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3110 FDA UDI
- Commercial Distribution
- Not 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
Gold Standard Diagnostics H. pylori ELISA IgA Test Kit by Gold Standard Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID
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
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 84ba849f-595b-4c38-bc96-efb9f04fe323 35 fields · synced Jun 8, 2026