Identity
- Trade Name
- Status H. pylori control FDA UDI
- Generic Name
- Helicobacter pylori total antibody IVD, control FDA UDI
- Device Name
- Status H. pylori control (2 x 1 mL) FDA UDI
- Model / Reference
- BSP-406C-00 FDA UDI
- Description
- Status H. pylori control (2 x 1 mL) FDA UDI
Identifiers
- Catalog Number
- BSP-406C-00 FDA UDI
- Primary DI / UDI-DI
- 10743816001171 FDA UDI
- GMDN Term
- Helicobacter pylori total antibody IVD, control FDA UDI
Classification
- 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
No
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
Yes
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 total antibody IVD, control
Status H. pylori control by Princeton Biomeditech Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 10c63b16-d605-48c4-b713-5de05a08cc0d 36 fields · synced Jun 6, 2026