Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- One Step + H Pylori Test FDA UDI
- Model / Reference
- 9004071 FDA UDI
- Description
- One Step + H Pylori Test FDA UDI
Identifiers
- Catalog Number
- 9004071 FDA UDI
- Primary DI / UDI-DI
- 10304040024154 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical 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
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
No
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, kit, rapid ICT, clinical
Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Helicobacter pylori antigen IVD, kit, rapid ICT, clinical.
- QuickVue — Quidel Corp. · Class I
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- INSTANT-VIEW H. pylori Rapid Test — Alfa Scientific Designs, Inc. · Class I
- ImmunoCard STAT! HpSA — MERIDIAN BIOSCIENCE, INC. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- AIMSTEP H. PYLORI — GERMAINE LABORATORIES, INC. · Class I
- INSTANT-VIEW H. Pylori Serum Cassette Test — Alfa Scientific Designs, 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI fb30043a-2116-4234-8bc0-241dec63136a 35 fields · synced Jun 1, 2026