产品信息 - hCG One Step Rapid Test Kit->medical diagnostic equipment

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Zhejiang Orient Gene Biotech Co., Ltd

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hCG One Step Rapid Test Kit

产品分类 :

生化科技->醫療器材->

产品规格

Country	CN
Brand	HEALGEN;ORIENT GENE;DS
Size	4 millimeters
Packing	20 tests/box or as request
Minimum Order	50,000 pieces
Payment Term	L/C T/T

产品描述

Port: Shanghai
Minimum Order Quantity: 50,000 Piece/Pieces
Supply Ability: 500,000 Piece/Pieces per Week
Payment Terms: L/C,T/T
Packaging & Delivery
Packaging Details: 25 tests/box or As requested
Delivery Detail: 3 ~ 4 weeks

Specifications
hCG One Step Rapid Test Kit
CE Certificate (CE 0197)
ISO 13485 Certifcate
FDA 510k Approval

Introduction:
The hCG One Step Rapid Test Kit is an immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine. The test is used to obtain a visual qualitative result.

Principle:
The hCG One Step Rapid Test Kit is a lateral flow chromatographic immunoassay based on the principle of the double antibodysandwich technique. The membrane is precoated with anti-hCG antibodies on the test line region.In the test procedure, the liquid sample is allowed to migrate through the absorbent area. If hCG is present, labeled antibody-dye conjugate binds it, forming an antibody-antigen complex. As the reaction mixture continues to flow along the test membrane, the complex binds to the anti-hCG antibody in the test (T) zone of the membrane, and produces a pink-rose color band. Unbound conjugate binds to the reagents immobilized in the control (C) zone producing a pink-rose color band, demonstrating proper performance of the test.

Product Feature:
A lateral flow rapid test
Simple, one step rapid test,no special training required
A qualitative, sandwich dye conjugate immunoassay for the determination of hCG in urine
In less than 5 minutes, elevated levels of hCG as low as 25 mlU/mL can be detected
Visual result, easy interpretation

Test Procedure
1. Remove a Testing Device from the foil pouch by tearing at the notch and place it on a level surface.
2. Holding a Sample Dropper vertically, add exactly 2-3 drops of urine specimen to the sample marked S.
3. Read results in 5 minutes. Do not read results after more than 5 minutes.

Interpretation of result
Positive(Pregnant)
Both C line and T line appear in the viewing window accordingly, indicating you are probably pregnant. One line may be lighter than the other, they do not have to match.
Negative (Not pregnant)
Only one line, the C line, appears in the control region, indicating you are probably not pregnant.
Invalid
The result is invalid if no red line appears in the control region, even if a line appears in the test region. You should repeat the test with a new midstream test.

Sensitivity: 25 mlU/mL, more sensitivite tests available on your request

Specificity: 99.9%

Materials provided
Each test contains :
1. One cassette device
2. One pipette dropper
3. One desiccant

Each kit contains:
1. 25 cassette devices
2. 1 instruction

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