FDA UDI
In Commercial Distribution
🇺🇸 United States
Detector UA 10
DI: 10722355002221
·
Model: IDU-10
·
IMMUNOSTICS COMPANY, INC
Product Codes
10
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Detector UA 10
- Primary DI
- 10722355002221
- Version / Model
- IDU-10
- Company Name
- IMMUNOSTICS COMPANY, INC
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 736b3984-df71-4c6f-8d91-e4c017de750a
Device Description
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
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 |
|---|---|---|---|---|
| JRE | REFRACTOMETER FOR CLINICAL USE | Clinical Chemistry | 862.2800 | 1 |
| JIL | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | Clinical Chemistry | 862.1340 | 2 |
| JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1115 | 1 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1785 | 1 |
| JMA | ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC) | Clinical Chemistry | 862.1095 | 1 |
| JMT | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | Clinical Chemistry | 862.1510 | 1 |
| JIR | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1645 | 1 |
| CEN | DYE-INDICATOR, PH (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1550 | 1 |
| LJX | TEST, URINE LEUKOCYTE | Hematology | 864.7675 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54514 | Multiple urine analyte IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. 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 |
|---|---|---|---|---|---|---|
| Package | 20722355002204 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 10722355002221 | GS1 | ||||
| Unit of Use | 80722355002220 | GS1 |
Customer Contacts
- Phone
- +1(732)918-0770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970250 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature