FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test
DI: 10673486014020
·
Model: P597-25
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test
- Primary DI
- 10673486014020
- Version / Model
- P597-25
- Catalog Number
- P597-25
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-09
- Public Version
- 1
- Public Version Date
- 2026-04-17
- Public Version Status
- New
- Public Device Record Key
- 3e3e6c32-cba9-47c2-9525-a4d1dd4eab92
Device Description
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66850 | Human chorionic gonadotropin beta-subunit 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 the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) 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 for early detection of pregnancy, as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage), or as an indicator of trisomy 21 (Down syndrome) during pregnancy. 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 | 10673486014020 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964462 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius