Unitest hCG Pregnancy Test, CE Marked

hCG Type of Packing

  • Unitest hCG Pregnancy Test Strip in Consumer packs of 1, 2, 3 or 5 units
  • Unitest hCG Pregnancy Test Cassette in Consumer packs of 1 unit
  • Unitest hCG Pregnancy Test Midstream in Consumer packs of 1 , 2, or 3 units
  • Unitest hCG Pregnancy Test Strip in  packs of 100 units
  • Unitest hCG Pregnancy Test Cassette in packs of 20 or 25 units

Unitest (also available private label OEM brand) HCG Urine Pregnancy Test for Self-Testing and for the Professional Use.

(Strip, Cassette and Midstream Formats)

The hCG Urine Pregnancy Tests are qualitative immunoassays for the determination of human Chorionic Gonadotropin (hCG) hormone in urine.

Qualitative results in 45 seconds

  • 25U/ml Sensitivity(also 10 MIU available)
  • 99.98% Accuracy

Test any time of day

These tests are easy to use, versatile and produce very fast results. With a built in test control, results appear as either single (negative) or double (positive) bands. The Unitest hCG Pregnancy Test has a sensitivity of 10ml-25U/ml and is therefore an effective aid in detecting early pregnancy.

Packaging available:

  • Bulk packaging, boxes of 25,50 and 100 pcs.. For hospitals, governments, ngo´s, etc.
  • Consumer packaging: Boxes of 1,2,3, 5 and 10 units, with the box and leaflet in any international language, special for the private sector: sales stores, pharmacies, supermarkets, etc.
  • Formats available: Strip, Cassette and Midstream.

HCG Pregnancy Test Midstream (Consumer packing)

HCG Pregnancy Test is a self-testing immunoassay made for the rapid, visual and qualitative determination of human chorionic gonadotropin(HCG) in urine specimen to aid in the early detection of pregnancy.

Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, HCG can be detected in serum as early as 7 days following conception. The concentration of HCG continues to rise rapidly, frequently exceeding 100mIU/mL by the first missed menstrual period and peaking in the 100,000-200,000mIU/mL range by 10-12 weeks into pregnancy. The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy.

The test midstream should be stored at temperature 2-30℃, the sealed pouch for the duration of the shelf time (36months).

HCG Pregnancy Strip (Consumer Packing)

This HCG Pregnancy Test (strip, cassette and midstream)detects HCG at a concentration of 25mlU/ml or greater.

Negative result will be found in the urine of healthy men and healthy non-pregnant women.However, healthypregnant women have HCG present in their urine and serum specimens. The amount of HCG will vary greatly with gestational age and between  individuals.

The HCG Pregnancy Test has an analytical sensitivity of 25mIU/mL, and is capable of detecting pregnancy as early as 1 day after the first missed menses.

HCG Pregnancy Cassette

Allow the test cassette, urine specimens and/or controls to equilibrate to room temperature prior to testing. Do not open pouches until ready to perform the assay.

1. Remove the test device from the sealed pouch and lay it on a flat, clean and dry surface. Use it as soon as possible.

2. Use the provided pipette to withdraw urine specimen from the urine container and dispense 3 drops into the sample well.

3. Wait for pink-colored lines to appear. Read results within 5 minutes. Do not read result after 5 minutes.

INTERPRETATION OF RESULTS

PREGNANT: Two distinct pink-colored lines appear, one in the test region (T) and the other one in the control region (C).
NOTE: The intensity of the pink color in the test region (T) may vary depending on the concentration of HCG present in the specimen. Therefore, any shade of pink color in the test region (T) should be considered positive.

NOT PREGNANT: Only one pink-colored line appears in the control region (C). No apparent pink line appears in the test region (T).
INVALID: Control line fails to appear.

                  Unitest LH Ovulation Test, CE Marked

LH type of Packing

  • Unitest LH Ovulation Strip in consumer packs of 5 or 10 units
  • Unitest LH Ovulation Cassette in consumer packs of 5 or 10 units
  • Unitest LH Ovulation Midstream in consumer packs of 5 or 10 units
  • Unitest LH Ovulation Strip in boxes of 100 units
  • Unitest LH Ovulation Cassette in boxes of 25 units
  • Unitest LH Ovulation Midstream in boxes of 25 units

One Step LH Urine OvulationTest

(Strip, Cassette and Midstream Formats)

Unitest LH Ovulation Test for Self-Testing (CE 0197 marked) and for the Professional Use.

The Unitest LH Urine Ovulation Tests are qualitative immunoassays for the determination of the LH luteinizing hormone in urine.

Ovulation Test Kits are for use in monitoring the ovulation cycle for couples trying to conceive.

Ovulation kits are designed to monitor increase in Luteinizing Hormone (LH) in urine. LH is a gonadotropin usually present in blood and urine with highest concentrations at 24-48 hours before the release of fertile egg. This condition is also commonly referred to as LH Surge and is a useful for timing of sexual intercourse, and ultimately conception.

Qualitative results in 45 seconds

  • 25U/ml Sensitivity
  • 99.98% Accuracy
  • CE 0197/ISO 13485 Certified

These tests are easy to use, versatile and produce very fast results. With a built in test control, results appear as either single (negative) or double (positive) bands.

Packaging Available:

  • Boxes of 5, 7, 10, 25, 100 pcs.

Formats Available:

  • Strip, Cassette and Midstream.

Other IVD Test

(under our brand Unitest or OEM Private Label)

Our effort has been oriented to develop colloidal gold one-step tests and membrane medical tests that are markedly different from other manufacturers in their superior material selection, advanced manufacturing and reliable quality control, all of which, including low cost, have contributed to our Company’s great advantage over our competitors.

Our joint venture has gathered under its roof a group of the finest scientists and specialists majoring in the field of bio-medical technology, material, engineering, manufacturing and information service.

Urine Test Product Range:

  • a) CE marked, for Self-Testing, Annex IV, IVD European Directive 79/98.
    • Products: HCG Pregnancy Test, LH Ovulation Test.
  • b) For the Professional Use, CE marked, Annex III. IVD European Directive 79/98.
  • c) Non CE marked
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