FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Up & Up
DI: 00829576076703
·
Model: Early Ovulation Test
·
TARGET CORPORATION
Product Codes
2
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Up & Up
- Primary DI
- 00829576076703
- Version / Model
- Early Ovulation Test
- Company Name
- TARGET CORPORATION
- Labeler DUNS
- 006961700
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-14
- Public Version
- 6
- Public Version Date
- 2025-07-31
- Public Version Status
- Update
- Public Device Record Key
- 378f9d70-d7e4-4b70-9741-de448f19caf4
- Distribution End Date
- 2025-07-30
Device Description
A convenience kit consisting of 10 Ovulation Test devices and 1 One Step Pregnancy Test.
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
- 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 |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | Clinical Chemistry | 862.1485 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33819 | Total human chorionic gonadotropin 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 total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, 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 to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing. | No | Active |
| 60862 | Natural conception assistance kit | A collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10829576076700 | GS1 | Shipping Case | 12 | Not in Commercial Distribution | 2024-01-30 |
| Primary | 00829576076703 | GS1 | ||||
| Package | 20829576076707 | GS1 | Shipping case | 6 | Not in Commercial Distribution | 2025-07-30 |
Customer Contacts
- Phone
- 1-800-899-7353
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius