Description
Indication & Scope
JIAOGUA® ONE STEP HCG URINE TEST is an OTC Class II in vitro diagnostic kit for in vitro qualitative detection of human chorionic gonadotropin (HCG) in female urine.
- Mechanism: Adopts colloidal gold immunochromatography principle to detect HCG in urine samples.
- Drug class: Class II In Vitro Diagnostic Reagent (IVD)
- Clinical use: For in vitro qualitative detection of human chorionic gonadotropin (HCG) in female urine.
| Generic Name | ONE STEP HCG URINE TEST |
| Brand Name | JIAOGUA® |
| Ingredient | Monoclonal anti-HCG antibody, sheep anti-mouse antibody, chloroauric acid, nitrocellulose membrane, glass fiber, polyester membrane, thick fiber |
| Dosage Form | In Vitro Diagnostic Test Kit |
| Package | 1 test per box |
| Conditions Treated | For in vitro qualitative detection of human chorionic gonadotropin (HCG) in female urine |
| Taboos | No absolute contraindications; test results are for reference only and cannot replace clinical diagnosis |
| Place of origin | China |
| Prescription type | Over‑the‑counter (OTC) |
| Storage Conditions | Store at 4-30℃, protected from light and dry |
| Manufacturer | Qingdao Aibo Detection Technology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA) |
| Approval number |
Medical Device Registration No.: 20162400576 |
| Approval Date | July 3, 2026 |
| Shelf Life | Please refer to product package or instruction manual for details |
How to use ?
Recommended Dose: In vitro test only, one pen-type kit for single test.
Time: Morning urine sample is recommended to get more accurate results.
Instructions for use: Collect urine sample, apply urine to the sample well of the test pen, read the result within the specified time.
Interaction: No drug interactions.
Side effects: No side effects. This is an in vitro diagnostic product and will not enter the human body.
Important Notice
- For in vitro diagnostic use only, not for internal use.
- The test result is for reference only; please confirm with hospital examination.
- Do not use if the package is damaged or expired.
- Store sealed at 4-30℃, keep away from light.
- Keep out of the sight and reach of children.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is JIAOGUA ONE STEP HCG URINE TEST used for?
It is a Class II IVD kit for in vitro qualitative detection of HCG in female urine to assist early pregnancy screening.
What are the storage requirements?
Store at 4-30℃, keep dry and away from light, shelf life is 36 months.
Can the test result be used as a final pregnancy diagnosis?
No, the result is only for reference. Confirmation by hospital examination is required.
Who manufactured this product?
Qingdao Aibo Detection Technology Co., Ltd.
JIAOGUA® | ONE STEP HCG URINE TEST | Early Pregnancy Screening | DengYueRX
INN: ONE STEP HCG URINE TEST (IVD Diagnostic Kit)
Indications: Early pregnancy screening
Dosage Form: In Vitro Diagnostic Test Kit
Strength: Pen type, single person/Box
Original price was: $1.24.$1.05Current price is: $1.05.
Availability: 5 in stock
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
Related Products
JIAOGUA® | ONE STEP HCG URINE TEST | Early Pregnancy Screening | DengYueRX
Original price was: $1.24.$1.05Current price is: $1.05.
Availability: 5 in stock
