Testsealabs hCG Pregnancy Test Strip Women Early Detection for Pregnancy

Short Description:

●Sample type: Urine sample

●Specification : Strip format

●High sensitivity:10miu/ml or 25miu/ml available

●High accuracy: 99.9%

●Fast Result：within 3 mins

●Certification: CE

●Specification: 50 strip in one bottle or box

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Product Detail

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INTRODUCTION

Testsealabs HCG Pregnancy Test Strip The hCG Pregnancy Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
For self-testing and in vitro diagnostic use only.

Product Name	One Step HCG Urine Pregnancy Test
Brand Name	Testsealabs
Dosage Form	In Vitro Diagnostic Medical Device
Methodology	Colloidal gold immune chromatographic assay
Specimen	Urine
Format	Strip/ Cassette/ Midstream
material	Paper + PVC(Strip) , ABS(Cassette & Midstream)
Sensitivity	25mIU/ml or 10mIU/ml
Accuracy	>=99.99%
Specificity	No across reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH and 1mIU/ml of hTSH
Reaction Time	22 seconds
Shelf Life	24months
range of application	all levels of medical units and home self-test.
Certification	CE,ISO,FSC

Type	Strip	Cassette	Midstream
Specification	2.5mm 3.0mm 3.5mm	3.0mm 4.0mm	3.0mm 4.0mm 5.5mm 6.0mm
Bulk package
Package	1PC x 100/bag	1PC x 40/bag	1PC x 25/bag
Plastic bag size	*280200mm**	*320220mm**	*320220mm**

PRODUCT FEATURE

Picture

Storage Conditions And Shelf Life

1.Store as packaged in the sealed pouch at room temperature (4-30℃ or 40-86℉). The kit is stable within the expiry date printed on the labeling.
2.Once open the pouch, the test strip should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

Materials Provided

●Specimen collection container
●Timer

Testing Method

Read the entire procedure carefully before performing any tests.
Allow test strip and urine specimen to equilibrate to room temperature (20-30℃ or 68-86℉) prior to testing.

1.Remove the test strip from the sealed pouch.
2.Holding the strip vertically, carefully dip it into the specimen with the arrow end pointing towards the urine.
NOTE: Do not immerse the strip past the Max Line.
3.Remove the strip after 10 seconds and lay the strip flat on a clean, dry, non-absorbent surface, and then begin timing.
4.Wait for colored lines to appear. Interpret the test results at 3-5 minutes.
NOTE: Do not read results after 5 minutes.

Interpretation of Results

Positive: Two distinct red lines will appear, one in the test region (T) and another in the control region (C). You can assume that you are pregnant.

Negative: Only one red line appears in the control region (C). No apparent line in the test region (T). You can assume that you are not pregnant.

Invalid: The result is invalid if no red line appears in the control region (C), even if a line appears in the test region (T). In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor.

NOTE: Clear background in the Result Region can be seen as a basis for effective testing. If the test line is weak, it is recommended that the test be repeated with the first morning specimen obtained 48-72 hours later. No matter how the test results, it is recommended to consult your physician.

Exhibition Information

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Company Profile

We, Hangzhou Testsea Biotechnology Co., Ltd is a fast-growing professional biotechnology company specialized in researching, developing, manufacturing and distributing of advanced in-vitro diagnostic(IVD) test kits and medical instruments.
Our facility is GMP, ISO9001, and ISO13458 certified and we have CE FDA approval. Now we are looking forward to cooperating with more overseas companies for mutual development.
We produce fertility test, infectious diseases tests, drugs abuse tests, cardiac marker tests, tumor marker tests, food and safety tests and animal disease tests, in addition, our brand TESTSEALABS have been well known in both domestic and overseas markets. Best quality and favorable prices enable us to take over 50% the domestic shares.