FDA UDI
In Commercial Distribution
🇺🇸 United States
HealthyMe UTI Urinary Tract Infection Test Strips
DI: 00682607651252
·
Model: 725125
·
Acon Laboratories, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
4
Pkg Device Count
3
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Basic Information
- Brand Name
- HealthyMe UTI Urinary Tract Infection Test Strips
- Primary DI
- 00682607651252
- Version / Model
- 725125
- Company Name
- Acon Laboratories, Inc.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-03-27
- Public Version
- 3
- Public Version Date
- 2025-06-20
- Public Version Status
- Update
- Public Device Record Key
- e0163624-8bd5-4982-aec1-345ec52a8aa6
Device Description
Urinary Tract Infection home test with handle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54520 | Urine leukocyte 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 leukocytes 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 |
| 54521 | Urine nitrite 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 nitrites 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 |
|---|---|---|---|---|---|---|
| Package | 20682607651256 | GS1 | Carton | 4 | In Commercial Distribution | |
| Primary | 00682607651252 | GS1 | ||||
| Unit of Use | 00682607003150 | GS1 | ||||
| Package | 10682607651259 | GS1 | Inner Pack | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit