Testsealabs hCG Pregnancy Test Midstream Urine Pregnancy Test
INTRODUCTION
Testsealabs HCG Pregnancy Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
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Product Name |
One Step HCG Urine Pregnancy Test |
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Brand Name |
Testsealabs |
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Dosage Form |
In Vitro Diagnostic Medical Device |
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Methodology |
Colloidal gold immune chromatographic assay |
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Specimen |
Urine |
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Format |
Strip/ Cassette/ Midstream |
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material |
Paper + PVC(Strip) , ABS(Cassette & Midstream) |
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Sensitivity |
25mIU/ml or 10mIU/ml |
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Accuracy |
>=99.99% |
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Specificity |
No across reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH and 1mIU/ml of hTSH |
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Reaction Time |
22 seconds |
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Shelf Life |
24months |
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range of application |
all levels of medical units and home self-test. |
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Certification |
CE,ISO,FSC |
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Type |
Strip |
Cassette |
Midstream |
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Specification |
2.5mm 3.0mm 3.5mm |
3.0mm 4.0mm |
3.0mm 4.0mm 5.5mm 6.0mm |
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Bulk package |
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Package |
1PC x 100/bag |
1PC x 40/bag |
1PC x 25/bag |
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Plastic bag size |
280*200mm |
320*220mm |
320*220mm |
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.
Remove the test midstream from the sealed pouch.
Remove the Cap and hold the midstream with the exposed Absorbent Tip pointing downward directly into your urine stream for at least 10 seconds until it is thoroughly wet.
NOTE: If you prefer, you can urinate into a clean and dry container, then dip only the Absorbent Tip of the midstream into the urine for at least 10 seconds.
After removing the midstream from your urine, immediately replace the Cap over the Absorbent Tip, lay the midstream on a flat surface with the Result Window facing, and then begin timing.
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 psician.
Exhibition Information
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.
Product Process
1.Prepare
2.Cover
3.Cross membrane
4.Cut strip
5.Assembly
6.Pack the pouches
7.Seal the pouches
8.Pack the box
9.Encasement
Professional technical engineer dedicated to guide you
According to your actual needs, choose the most reasonable overall design and planning procedures