FDA UDI
In Commercial Distribution
🇺🇸 United States
SURESIGN™ Early Detection Pregnancy Test
DI: 00045611010017
·
Model: 01001-7
·
Guangzhou Decheng Biotechnology Co., LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- SURESIGN™ Early Detection Pregnancy Test
- Primary DI
- 00045611010017
- Version / Model
- 01001-7
- Company Name
- Guangzhou Decheng Biotechnology Co., LTD
- Labeler DUNS
- 554534314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2026-01-28
- Public Version
- 1
- Public Version Date
- 2026-02-05
- Public Version Status
- New
- Public Device Record Key
- 7dec0265-7c5e-438d-a7fc-aa4396f243ea
Device Description
5ct 10mIU - 6 Day Early Pregnancy Test
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 |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 50045611010012 | GS1 | ||||
| Primary | 00045611010017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240643 | 000 |