Identity
- Trade Name
- Status™ H. pylori card FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Status™ H. pylori card; 30 Test kit- CE (Procedure Card) FDA UDI
- Model / Reference
- BSP-406WB-30-07 FDA UDI
- Description
- Status™ H. pylori card; 30 Test kit- CE (Procedure Card) FDA UDI
Identifiers
- Catalog Number
- BSP-406WB-30-07 FDA UDI
- Primary DI / UDI-DI
- 10743816001164 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Status™ H. pylori card by Princeton Biomeditech Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA).
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- Status™ H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI c1508c61-2ac2-4318-a653-75ebeede1bc6 36 fields · synced May 30, 2026