Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
- Device Name
- Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma. FDA UDI
- Model / Reference
- HPY-13C15 FDA UDI
- Description
- Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma. FDA UDI
Identifiers
- Catalog Number
- HPY-13C15 FDA UDI
- Primary DI / UDI-DI
- 00722066000304 FDA UDI
- 510(k) Number
- K024350 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test 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
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test.
- Detector H. pylori — IMMUNOSTICS, INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Detector H. pylori — IMMUNOSTICS, INC. · Class I
- PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 338c89a4-68c5-4804-8f32-04af13ed4f14 35 fields · synced Jun 8, 2026