FDA UDI
In Commercial Distribution
🇺🇸 United States
MedMira Rapid H. Pylori Antibody Test
DI: 00628451188278
·
Model: 815311003820
·
MedMira Laboratories Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MedMira Rapid H. Pylori Antibody Test
- Primary DI
- 00628451188278
- Version / Model
- 815311003820
- Company Name
- MedMira Laboratories Inc
- Labeler DUNS
- 243757049
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-09
- Public Version
- 1
- Public Version Date
- 2024-07-17
- Public Version Status
- New
- Public Device Record Key
- 4a3c692c-c0d1-401b-8115-7899ede9c437
Device Description
The MedMira Rapid H. Pylori Antibody Test is a rapid flow through test developed and manufactured by MedMira Laboratories Inc.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 30825 | Helicobacter pylori antigen IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with H. pylori which is associated with gastroduodenal disorders such as active chronic gastritis and gastric/duodenal ulcers. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628451188278 | GS1 |
Customer Contacts
- Phone
- 902-450-1588
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002023 | 000 |