Identity
- Trade Name
- OSOM H. Pylori Control Kit FDA UDI
- Generic Name
- Helicobacter pylori antigen IVD, control FDA UDI
- Model / Reference
- 176 FDA UDI
Identifiers
- Catalog Number
- 176 FDA UDI
- Primary DI / UDI-DI
- 00742860100178 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Helicobacter pylori antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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 antigen IVD, control
OSOM H. Pylori Control Kit by Sekisui Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI ee163378-9194-45d8-aa44-7046a74d524a 33 fields · synced Jun 9, 2026