OEM FDA HCG Pregnancy Home Use Rapid Test Kit

Customization: Available
Accuracy: 99.5%
Sensitivity: 25mlu/Ml, 10mlu/Ml

Products Details

Basic Info.

Model NO.
SP-004
Format
Strips, Cassettes, Midstreams
Type
IVD Reagent
Transport Package
Carton
Trademark
SD
Origin
Beijing
HS Code
3822190090

Product Description

OEM FDA HCG Pregnancy  Home Use Rapid Test Kit

Principle:


HCG One step Pregnancy Rapid Test The HCG One Step Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of HCG in urine to aid in the early detection of pregnancy.

It is normally made only during pregnancy.

 
Produt name urine pregnancy test
Sensitivity 25mlU/mL, 10mlU/mL
Accuracy More than 99.5%
Shelf time 24-36 month
OEM time 20 days
Certificate CE/ISO13485/FDA
Specimen Urine
Format Strip /Cassette /Midstream
Size Strip: 2.5mm
  Cassette :/4mm
  Midstream:5mm
Usage Read results within 5 minutes

Picture Display:
OEM FDA HCG Pregnancy Home Use Rapid Test KitOEM FDA HCG Pregnancy Home Use Rapid Test KitOEM FDA HCG Pregnancy Home Use Rapid Test KitOEM FDA HCG Pregnancy Home Use Rapid Test KitOEM FDA HCG Pregnancy Home Use Rapid Test Kit

 

TEST PROCEDURE:

1. Bring the pouched test midstream to room temperature(15-30ºC) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test midstream from the sealed pouch.
3. Remove the Cap and turn around the midstream to show the Absorbent Tip.
4. Hold the midstream by the Thumb Grip with the exposed absorbent tip pointing downward. Urinate on the absorbent tip directly till it is thoroughly wet (at least 5 seconds).
NOTE: Be careful and do not urinate in the Show Window.
5. Re-cap the test midstream and lay it on a flat surface with window side up .
6. Wait for pink-colored lines to appear. Read results within 5 minutes. Do not read results after 5 minutesOEM FDA HCG Pregnancy Home Use Rapid Test Kit

Interpreting results:

PREGNANT: Two distinct pink-colored lines appear, one in the test region (T) and 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.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control 

line failure. Review the procedure and repeat the test with a new test midstream. If the problem persists, please 

contact your local distributor.  

Package:
 
Product Name Specimen Format Package Size
HCG Pregnancy Test Urine Strip 1Test/foil pouch, 100test/box
  Cassette 1Test/foil pouch, 1Test/ or 25 Tests/box
  Midstream 1Test/oil pouch, 1T/Box, 2T/Box or 5 T/box

Shipping:

By ship, plane or express according to quantity

One Step Fertility & Eugenic Test Products Profile
 
Product
Specimen
Type
Sensitivity
Pregnancy HCG Test Kit
Urine/Serum
strip/cassette/midstream
25mIU/ml
Digital Pregnancy Test Kit
Urine
midstream
25mIU/ml
Ovulation (LH) Test Kit
Urine
strip/cassette/midstream
25mIU/ml
FSH(Follicle-stimulating Hormone)
Urine
strip/cassette/midstream
25mIU/ml
fFN(Fetal Fibronectin)
cervical mucus
strip/cassette
25ng/ml
Sperm-density
Semen
cassette
N/A
HSV I lgG/lgM
whole blood/ serum/plasma
cassette
N/A
HSV II lgG/lgM
whole blood/ serum/plasma
cassette
N/A
HSV 1+2 lgG/lgM
whole blood/ serum/plasma
cassette
N/A
TOXO IgG/IgM
whole blood/ serum/plasma
cassette
N/A
RV IgG/IgM
whole blood/ serum/plasma
cassette
N/A
CMV IgG/IgM
whole blood/ serum/plasma
cassette
N/A
TORCH IgM combo-5
whole blood/ serum/plasma
cassette
N/A
TORCH IgG/IgM combo-5
whole blood/ serum/plasma
cassette
N/A

 

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