FDA UDI
In Commercial Distribution
🇺🇸 United States
Accutest
DI: 10763924410146
·
Model: UA704A
·
JANT PHARMACAL CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Accutest
- Primary DI
- 10763924410146
- Version / Model
- UA704A
- Company Name
- JANT PHARMACAL CORPORATION
- Labeler DUNS
- 797393659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 5732af5b-8c41-4bbd-8ff7-168020a83710
Device Description
4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | 862.1510 | 1 |
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43539 | Urine catalase IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. 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 | 10763924410146 | GS1 | ||||
| Unit of Use | 00763924410149 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052719 | 000 |