xinzhiyun hcg test kit pen type 1pen per box

Description

Indication & Scope

XinZhiYun® (Human Chorionic Gonadotropin (HCG) Test Kit (Colloidal Gold Method)) 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 colloidal gold immunochromatography. HCG in urine binds to colloidal gold-labeled antibodies and produces a colored line in the test region (T). The control region (C) confirms test validity.
Device class: Class II in vitro diagnostic medical device.
Clinical use: Qualitative urine screening for HCG to assist in pregnancy assessment. The result is for preliminary reference and is not sufficient to confirm pregnancy.

Specification

Generic Name	Human Chorionic Gonadotropin (HCG) Test Kit (Colloidal Gold Method)
Brand Name	XinZhiYun®
Ingredient	It consists of test pen (colloidal‑gold‑labeled conjugate pad, nitrocellulose membrane, sample pad, absorbent paper, plastic pen housing) and individual aluminum‑foil pouch packaging; no sample diluent is included. For single‑use only.
Dosage Form	Test Pen
Package	1 test pen/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 the test pen with a clean urine sample. First-morning urine is preferred.

Time: Avoid excessive fluid intake for 2 hours before testing. For better reliability, testing is generally recommended after a missed period or approximately 10–14 days after intercourse.

Instructions for use: 1. Open the foil pouch and remove the test pen. Remove the cap to expose the absorbent tip. 2. Either urinate directly onto the absorbent tip for 5–10 seconds or immerse the tip in a clean urine container for 5–10 seconds. 3. Replace the cap and place the test pen horizontally on a clean, dry surface. 4. Read the result within 5–10 minutes. Results read after 15 minutes are invalid. Positive: Both the T and C regions show colored lines, regardless of the intensity of the T line. Negative: Only the C region shows a clear colored line. Invalid: No colored line appears in the C region. Repeat the test with a new device.

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

Side effects: This in vitro diagnostic device 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 HCG in female urine to assist in determining pregnancy.

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

First-morning urine is preferred. Testing after a missed period may provide more reliable results.

What does a positive result mean?

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

What if the result is negative but my period is delayed?

Early pregnancy may produce a negative result. 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 Pen
Strength: 1 pen/Box

Original price was: $0.55.Current price is: $0.47.

Availability: 5 in stock