xinzhiyun hcg test kit card type 1card per box

Description

Indication & Scope

XinZhiYun® (HCG Test Kit) is a Class II in vitro diagnostic device intended for the qualitative detection of human chorionic gonadotropin (HCG) in female urine to assist in determining pregnancy.

Mechanism: The test uses a colloidal gold immunochromatographic double-antibody sandwich method. HCG in the urine binds to colloidal gold-labeled antibodies and forms a colored line in the test region (T). The control region (C) indicates that the test is valid.
Device class: Class II in vitro diagnostic medical device.
Clinical use: Qualitative urine screening for HCG to assist in pregnancy assessment. The test is intended for preliminary screening and cannot be used as the sole basis for pregnancy diagnosis.

Specification

Generic Name	Human Chorionic Gonadotropin (HCG) Test Kit (Colloidal Gold Method)
Brand Name	XinZhiYun®
Ingredient	It consists of a cassette‑type test reagent (colloidal‑gold‑labeled conjugate pad, nitrocellulose membrane, sample pad, absorbent paper, plastic cassette), individual aluminum‑foil pouch packaging and plastic dropper. Sample diluent is not included.
Dosage Form	Test Card
Package	1 test card + 1 dropper/box
Conditions Treated	Qualitative detection of HCG in female urine to assist in determining pregnancy
Taboos	For in vitro use only; not intended as the sole basis for pregnancy diagnosis.
Place of origin	China
Prescription type	Class II In Vitro Diagnostic Medical Device
Storage Conditions	Store at 4°C–30°C in a dry place protected from light. Do not freeze.
Manufacturer	Shandong Aibo Biotechnology Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	Shandong Medical Device Registration No. 20162400576
Approval Date	May 23, 2016
Shelf Life	36 months

How to use ?

Recommended Dose: Use a clean, fresh urine sample. First-morning urine is preferred.

Time: Avoid excessive fluid intake for 2 hours before testing. Testing approximately 10–14 days after intercourse or after a missed period may provide more reliable results.

Instructions for use: 1. Open the foil pouch and remove the test card and dropper. Place the card on a clean, dry, level surface. 2. Use the dropper to collect fresh urine and add 3–4 drops (approximately 0.2 mL) to the sample well. 3. Read the result within 5–10 minutes. Any result appearing after 15 minutes is invalid. Positive: Both the T and C regions show red lines, regardless of the intensity of the T line, indicating possible pregnancy. Negative: Only the C region shows a clear red line, with no red line in the T region. Invalid: No red line appears in the C region. Repeat the test using a new device.

Interaction: HCG-containing medicines and certain medical conditions may affect test results. Consult a healthcare professional when the result is inconsistent with clinical circumstances.

Side effects: This is an in vitro diagnostic device and is not expected to cause systemic adverse reactions when used as directed.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

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

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What does XinZhiYun® (HCG Test Kit) detect?

XinZhiYun® (HCG Test Kit) qualitatively detects human chorionic gonadotropin (HCG) in female urine to assist in determining pregnancy.

When is the best time to use the XinZhiYun® (HCG Test Kit) test card?

First-morning urine is preferred. XinZhiYun® (HCG Test Kit) testing after a missed period or approximately 10–14 days after intercourse may provide more reliable results.

What does a positive result mean?

Two red lines in the C and T regions indicate a positive screening result and suggest possible pregnancy. Medical confirmation is recommended.

What should I do if the result is negative but my period is delayed?

A negative result may occur when HCG levels are still too low. Consider repeating the test and consult a healthcare professional if menstruation remains delayed.

XinZhiYun® | HCG Test Kit | Pregnancy Test | DengYueRX

INN: Human Chorionic Gonadotropin (HCG) Test Kit (Colloidal Gold Method)
Indications: Pregnancy testing
Dosage Form: Test Card
Strength: 1 card/Box

Original price was: $1.12.Current price is: $0.95.

Availability: 5 in stock