Find Verified Diagnostic Kits Suppliers, Manufacturers and Wholesalers

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

This test has been authorized by the FDA under a EUA for professional use CLIA and CLIA WAIVED for Point Of Care.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

This product is intended for professional use and not for home use.

FACT SHEET FOR HEALTHCARE PROVIDERS

This test has been authorized by the FDA under a EUA for use by authorized CLIA laboratories. This device is CLIA waived for point of care use for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
There should be a blue line in the control region (next to ) before testing, discard the device if there is no blue line.

Health Canada Authorised Rapid Test
The COVID-19 antigen rapid test device is a lateral flow in-vitro immunoassay intended to be used for the qualitative detection of the SARS-CoV-2 viral nucleoprotein. This device will detect both viable and nonviable virus in both nasopharyngeal and oropharyngeal secretions.
This test had been authorized for point of care use by Health Canada and is available for immediate dispatch

MediGuard Systems of Canada is an Authorised distributor of the Assuretech Rapid Antigen test.

Support documentation and details available on request

Product Name:
Surplex(R)-COVID-19 IgM/IgG Rapid test

Product Description:
Surplex(R)-COVID-19 IgM/IgG Rapid test is a serology test intended for the qualitative detection of IgM and IgG antibodies of the novel coronavirus (the SARS-COV-2 virus) in human serum, plasma or whole blood. It is CE marked and approved in Brazil (ANVISA approved).
We are motivated to aggressively price our product and ready to send 20 tests (one box) to qualified buyers for evaluation, free of charge.

Price of product:
FOB USD $1.50 - $2.50 per test, volume dependent.

Product origin :
China.

Key Specifications/Special Features :
- Competitively priced and ready to ship in volume.
- Currently shipping in volume to Brazil.
- Highly accurate and specific - performance independently confirmed.
- Results ready in 15 minutes.
- Harmonization System (HS) Code: 382200.
- We provide a full support during regulatory application.

Minimum Order Size and Packaging details:
MOQ: Flexible.
Box of 20 or 50 test kits.
Storage: 2-30C.
Shelf Life: 10 months.

Kind :
Novel coronavirus pneumonia

Standard :
Suitable for 2019-nCoV and flu A/B nucleic acid detection

Certification :
CE

Packing :
1;2;10;20;30;40 50ä
;2;10;20;30;40 50 Tests / Kit

Unit Price ï¼?USDï¼? FOB :
9.12

Aelivery Time :
7Days after signing the contract

500k per day

Kind :Novel coronavirus pneumonia and flu A/B Nucleid Acid Detection kit

Standard :
Suitable for 2019-nCoV and flu A/B nucleic acid detection

Certification :
CE

å??è£?
Packing :
50
50 Tests / Kit

Unit Price FOB :
9.12

Delivery Time :
within one week
300k per day

Kind :
Novel coronavirus pneumonia

Standard :
Suitable for 2019-nCoV and flu A/B nucleic acid detection

Certification :
CE

Packing :
10 T/box 20 T/box

Unit Price ï¼?USDï¼? FOB :
9.12

Aelivery Time :
7Days after signing the contract


Yield :
500k per day

Certificate :
CE

Model :
2019-nCov IgG/IgM Detection Kit (Colloidal Gold-Based)

MOQ :
100k

Payment Term :
T/T

Lead Time :
2 Months

Certificate :
CE

Model :
2019-nCov IgG/IgM Detection Kit (Colloidal Gold-Based)

MOQ :
100K

pcs/package :
32

Payment Term :
T/T

Lead Time :
4-5 days

Certificate :
CE

Model :
Nucleic Acid Detection

MOQ :
30000

Payment Term :
T/T

Others :
CIP

Lead Time :
7 days

Made in Canada
Health Canada approved
CE Mark and ISO certified
The product has proven to have 100% Specificity and 96% Sensitivety

Stock availabity: 2 Million tests/kit in Canada
Production: up to 5 Million tests/kit weekly

The Rapid Response COVID-19 Antigen Rapid Test Device is an in vitro immunochromatographic assay for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasal and nasopharyngeal secretions from individuals suspected of COVID-19 within 6 days of symptom onset. This test is authorized for use at the Point of Care i.e., in patient care setting. Results are for the identification of SARS-CoV-2 viral nucleoprotein antigen. Antigen is generally detectable in nasopharyngeal and nasal secretions during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories are required to report all positive results to the appropriate public health authorities. Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patientâ??s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The Rapid Responseâ?¢ COVID-19 Antigen Rapid Test Device is for use at the Point of Care for professional use only.

PRODUCT INFORMATION:

Product: Rapid Respose
Sample: Nasal / Nasopharyngeal secretions
Format: Cassette
Quantity: 25 Tests/Kit per box
Time to result: 15 minutes
Storage Condition: 2-30 C/36-86 F
Test Principle: Immunochromatographic Assay

CONTENTS - Individually packed test devices
Extraction Buffer
Extraction tube
Nozzle with filter
Tube stand
Individually packed swabs
Package Insert

Everything needed to run a test with materials provided in each kit:

20 Rapid SARS-CoV-2 Antigen Test Cards
(Individually packaged)
2 Sample Buffer
20 Sterilized swabs (Individually packaged)
20 Extraction tubes (Individually packaged)
1 Instruction for use
1 Tube rack (for 6 tubes/rack)
Product Information:
Quantity: 20 tests/kit
Sample type: Nasopharyngeal swab
Storage temperature: 2-30 C
Shelf life: 18 months
Test time: 15-20 minutes

Intended Use:
This product is authorized and intended for use by trained laboratory or healthcare professionals for in vitro diagnostic use. Point-of-care professionals administering tests are required to report all results to the appropriate public health authorities.
Note: Consult your provincial and local health care authorities for POC guidelines for rapid testing use.

The CareStart COVID-19 Antigen test kit allows for the rapid screening of COVID-19 infection on a large scale, with results in just 10 minutes. The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers. This product is CLIA waived under FDA/EUA authorization.

Quantity: 8 Million test kits
MOQ: 1 Million
FOB: New Jersey USA
Price: 11.75 USD

Rapid Test Kit COVID-19 IgG/Igm. Standard certification. FDA CE 38220090.00 ( Including in the WHO listing) MQO 10,000 units

Antigen Rapid Test is used for the in vitro qualitative detection of a novel coronavirus in the throats swabs.

FDA approved.