What is the accuracy of the test?

The test has an accuracy of more than 99%.

How early can the test detect pregnancy?

It can detect pregnancy as early as 1 day after a missed period.

What is the shelf life of the test kit?

The shelf life is between 24 and 36 months.

What specimen types are supported?

The test supports both urine and serum specimens.

Is customization available for this product?

Yes, we offer full, minor, and flexible customization from samples or designs.

What formats are available for the test?

The test is available in Strip, Cassette, and Midstream formats.

What are the sensitivity levels?

Sensitivity options include 10 mIU/mL, 15 mIU/mL, and 25 mIU/mL.

How do I read the test results?

One red line at the control line indicates negative; two lines indicate positive; no color indicates an invalid test.

Home

Health & Medicine

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

Equinox Biotech Co., Ltd.

7 yrs

Send Inquiry

Chat Now

Product Highlights

FDA and CE Approved: Certified with FDA and CE marks for safety and compliance.
High Accuracy Rate: Accuracy exceeds 99% for reliable pregnancy detection.
Early Detection Capability: Detects pregnancy as early as 1 day after a missed period.
Flexible Customization: Offers full, minor, and flexible customization from samples or designs.
Long Shelf Life: Valid for 24 to 36 months when stored at room temperature.
Multiple Formats Available: Available in Strip, Cassette, and Midstream formats.
Versatile Specimen Types: Compatible with both urine and serum specimens.
High Sensitivity Options: Sensitivity levels available at 10, 15, and 25 mIU/mL.

Product Attributes

Customization: Available
Type: IVD Instrument
Sensitivity: 10 Miu/Ml;15miu/Ml;25miu/Ml
Model NO.: RH-HCG-C
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
Specification: 2.8mm/3.0mm/4.0. mm
Trademark: DAVID, RUNBIO, OEM
Origin: Guangdong, China
Production Capacity: 400000 Piece/Pieces Per Day

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit pictures & photos — Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

Add Inquiry Basket to Compare

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

1/7

Find Similar Products

Product Description

The One Step hCG test is a rapid test to detect the presence of HCG in urine or serum specimens in a qualitative format sensitive to 15mIU HCG/ml. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated level of HCG in urine or serum. The immunological specificity of the test virtually eliminates cross reactivity interferences from the structurally related glycoprotein hormones hFSH, hLh, hTSH at physiological levels.

Key Features:

Easy to use
Easy to read
Able to test any time of day
Detect pregnancy as early as 1 day after the missed period
Room temperature storage

Specifications:
1) Specimen: urine; serum/urine
2) Format: strip, cassette, midstream
3) Sensitivity: 15mIU/mL
4) One kit includes 1 test (with desiccant) in a foil pouch

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. Draw 3 drops of urine sample into the pipette and dispense it into the sample window on the cassette.

3. Wait for 5 minutes and read results. Do not read results after 15 minutes.
Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

How to read the results

*Negative: If there is only one red line appears in the control line (C), it means that you are not pregnant.

*Positive: If there are two red lines appear in the show window(both in the control line and the test line) , it means that you are pregnant.

*Invalid: A total absence of color in both lines is the indication of error procedure and/or means that test reagent deterioration has occurred.

Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

About the Supplier

This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR241285". Items marked "" are certified.

Company Profile

Founded in 2001, Equinox Biotech Co., Ltd. is located in the China and Israel Science and Technology Innovation Cooperation Zone (Shantou) covering an area of 20, 000 m2.

We have gotten CE and ISO 13485 certificates. Our production management is strictly in accordance with the international quality management system to ensure product quality.

Relying on the advantages of talents and technology, we have established a perfect industrialization system of R&D, production and marketing in the field of bio diagnosis, which provides a powerful driving force to the company's sustainable development.

We have world-leading production lines and experienced staffs with a daily production capacity of 2 million test kits.

Our main products are rapid diagnostic kits covering areas like fertility diagnosis, drug of abuse detection, rapid diagnosis of infectious diseases and tumor detection. At present, we have obtained 510 (K) approval, Health Canada approval and CE certification for some of the products. Because of excellent quality, such as good reproducibility and specificity, high sensitivity and easy operation, and competitive price, they are favored by customers from the United States, Europe, Africa, Middle East, Asia, South America, South Asia and other international markets.

We are committed to providing people with products and services of outstanding quality, thus making their lives easier and more convenient.

About Our Factory & Business Background

Business Type: Manufacturer/Factory & Trading Company
Address: Rongsheng Technological Zone, University Road, Shantou, Guangdong, China
Plant Area: 16245 square meters
Number of Employees: 543
Registered Capital: 60,000,000 RMB
Terms of Payment: T/T, Small-amount payment
International Commercial Terms(Incoterms): FOB, CIF, CFR, EXW
Average Lead Time: Peak Season Lead Time, one month, Off Season Lead Time, within 15 workdays
Nearest Port: Shantou Port, Shenzhen Port
Minimum Order Quantity: 1000 PCS
Supply Chain Partners: 20

Our Production Capability & Technical Expertise

Main Products: HCG Pregnancy Test, Lh Ovulation Test, Fsh Test, Male Sperm Test, Drug Test, HIV Test, HCV Test, HBV Test
Production Lines: 3
Production Machines: Automatic Packaging Facility
Inspection Type for Finished Products: Random inspection Visual inspection Function inspection
Inspection Method for Finished Products: Have instructions and uniformly followed
Customization Options: Customization from Samples,Customization from Designs,Full Customization,Minor Customization,Flexible customization
ODM Service Available: Yes
OEM Service Available: Yes
R&D Engineers: 22 people
Traceability of Raw Materials: Yes
Own Brand: Yes

Our Industry Experience & Global Business Record

Year of Establishment: 2001-04-30
Export Year: 20 years
Main Markets: Southeast Asia/ Mideast
Repeat Buyers Choice: 50%~80%
Number of Foreign Trading Staff: 8
Overseas Agent/Branch: No

Our Certifications, Standards & Industry Recognition

Management System Certification: ISO9001:2015
Cooperated with Fortune 500: No

FAQ

What is the accuracy of the test?: The test has an accuracy of more than 99%.
How early can the test detect pregnancy?: It can detect pregnancy as early as 1 day after a missed period.
What is the shelf life of the test kit?: The shelf life is between 24 and 36 months.
What specimen types are supported?: The test supports both urine and serum specimens.
Is customization available for this product?: Yes, we offer full, minor, and flexible customization from samples or designs.
What formats are available for the test?: The test is available in Strip, Cassette, and Midstream formats.
What are the sensitivity levels?: Sensitivity options include 10 mIU/mL, 15 mIU/mL, and 25 mIU/mL.
How do I read the test results?: One red line at the control line indicates negative; two lines indicate positive; no color indicates an invalid test.