• OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
  • OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
  • OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
  • OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
  • OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
  • OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits

OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits

Type: IVD Instrument
Sensitivity: 10 Miu/Ml;15miu/Ml;25miu/Ml
Accuracy: More Than 99%
Certificate: Ce/ISO13485/FDA
Specimen: Urine, Serum
Format: Strip /Cassette /Midstream
Customization:

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Basic Info.

Model NO.
pregnancy test strip kits
Transport Package
Individual Packed in Foil Pouch
Specification
2.5mm/3.0mm/4.0. mm
Trademark
DAVID, RUNBIO, OEM
Origin
Shantou, China
Production Capacity
400000 Piece/Pieces Per Day

Product Description

                                HCG Pregnancy test       

Product name

HCG Pregnancy test

Sensitivity

10 miu/ml;15miu/ml;25miu/ml

Accuracy

more than 99%

Shelf time

24-36 month

OEM time

15-35 days

Certificate

CE/ISO13485/FDA

Specimen

Urine,Serum

Format

Strip /Cassette /Midstream

Size

Strip: 2.5mm/3.0mm/3.5mm/4.0mm/5mm

 

Cassette :3mm/4.2mm

 

Midstream:4mm/6mm

Usage

Read results within 10-15 


OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits
OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits

How to operate the test

1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.

2. Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse pass the MAX (maximum) line. Take the strip out after 3 seconds and lay the strip flat on a clean, dry and non-absorbent surface (e.g. mouth of the urine container).

3. Wait for red lines to appear, depending on the concentration of HCG in the test specimen. Positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required. Do not read results after 15 minutes.
OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits

 

How to read the results

Negative: Only one red line appears on the control region. No apparent line on the test region. There is no pregnancy.

Positive: Distinct red lines appear on the control and test regions. Both test line and control lines indicate that you are pregnancy. Color intensity of the test lines may vary. Different stages of the pregnancy have different concentration of HCG level.

Invalid: No visible line at all. Repeat test with a new test strip.

OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits OEM Package CE FDA 510K Approval HCG Accurate One Step Lab Pregnancy Test Strip Kits







 

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Plant Area
16245 square meters
Management System Certification
ISO9001:2015, ISO 13485 Certificate