Identity
- Trade Name
- H.PYLORI FDA UDI
- Generic Name
- Multiple gastrointestinal disease marker IVD, reagent FDA UDI
- Model / Reference
- AM880-10M FDA UDI
Identifiers
- Catalog Number
- AM880-10M FDA UDI
- Primary DI / UDI-DI
- 00810119676252 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Multiple gastrointestinal disease marker IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Multiple gastrointestinal disease marker IVD, reagent
H.pylori by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple gastrointestinal disease marker IVD, reagent.
- H.PYLORI — Biogenex Laboratories, Inc. · Class I
- H.PYLORI — Biogenex Laboratories, Inc. · Class I
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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI ebec1aac-b391-4f10-b8c7-02465f0a7464 36 fields · synced Jun 8, 2026