Identity
- Trade Name
- Monobind Qsure H. Pylori Control Set FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control FDA UDI
- Model / Reference
- HPC-300 FDA UDI
Identifiers
- Catalog Number
- HPC-300 FDA UDI
- Primary DI / UDI-DI
- 00816870020211 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Helicobacter pylori immunoglobulin A (IgA)/IgG antibody 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 2 Inch FDA UDI
Category: Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control
Monobind Qsure H. Pylori Control Set by Monobind, Inc. — Class I — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI c5e77eec-b28f-4e43-8192-a41d24863e3e 36 fields · synced May 30, 2026