FDA UDI
In Commercial Distribution
🇺🇸 United States
Accutest H. Pylori Urease Rapid Test
DI: 10763924750044
·
Model: ID750
·
JANT PHARMACAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Accutest H. Pylori Urease Rapid Test
- Primary DI
- 10763924750044
- Version / Model
- ID750
- Company Name
- JANT PHARMACAL CORPORATION
- Labeler DUNS
- 797393659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-04-21
- Public Version
- 1
- Public Version Date
- 2026-04-29
- Public Version Status
- New
- Public Device Record Key
- 9b098ddb-3991-4071-8731-6aafc52704ae
Device Description
Accutest H. pylori Urease Test is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pylori in symptomatic adult patients.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 52787 | Helicobacter pylori urease IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10763924750044 | GS1 | ||||
| Unit of Use | 00763924750047 | GS1 |
Customer Contacts
- Phone
- (800)676-5565
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052708 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.6 | Pound | |
| Length | 5.75 | Inch | |
| Width | 3 | Inch | |
| Height | 2.25 | Inch |