FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DAVID Ovulation Test (Urine)
DI: 06938444980043
·
Model: 80043
·
Equinox Biotech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- DAVID Ovulation Test (Urine)
- Primary DI
- 06938444980043
- Version / Model
- 80043
- Catalog Number
- RH-LH-S01
- Company Name
- Equinox Biotech Co., Ltd.
- Labeler DUNS
- 545868502
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 4
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- af0523f9-f9ea-4058-89ff-7c38aca46ff7
- Distribution End Date
- 2016-08-08
Device Description
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Clinical Chemistry | 862.1485 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54255 | Luteinizing hormone (LH) 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 luteinizing hormone (LH) 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. 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 | 06938444980043 | GS1 | ||||
| Unit of Use | 06938444980111 | GS1 |
Customer Contacts
- Phone
- 310-5320009
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 35.6 – 86 Degrees Fahrenheit