FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066000304
·
Model: HPY-13C15
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066000304
- Version / Model
- HPY-13C15
- Catalog Number
- HPY-13C15
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 4
- Public Version Date
- 2023-04-20
- Public Version Status
- Update
- Public Device Record Key
- 338c89a4-68c5-4804-8f32-04af13ed4f14
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYR | Helicobacter Pylori | Microbiology | 866.3110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62029 | Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test | A collection of reagents and other associated materials intended to be used for the qualitative detection of immunoglobulin G (IgG) antibodies to Helicobacter pylori in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses, and is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment. Infection with H. pylori is associated with gastroduodenal disorders such as active chronic gastritis, gastric, and duodenal ulcers. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00722066000304 | GS1 | ||||
| Unit of Use | 00722066004258 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024350 | 000 |