Find Verified Rt Pcr Test Kits Suppliers, Manufacturers and Wholesalers

USD$15.00

Origin: Korea
Certification: USA FDA EU under application, CE approved, WHO Compliant
Validated to: Bio-Rad CFX96
Target Genes: Rdrp, E
Weekly Production cap: 200,000
MOQ: 10,000 tests (100 kits)
Special D/C price: $15.00 USD test

Product Description :
The PaxView COVID -19 real-time RT-PCR Kit detects the novel coronavirus, COVID-19 using one-step real-time RT-PCR in a single tube intended for in vitro diagnostic use. The target genes for the detecton of the virus are Orf1ab and N gene. The sequence of primers and probes for the amplification were adapted from sources published by China CDC and WHO. The kit includes primers and probe set targeting the human RNase P gene that serves as an internal positive control for the real-time RT-PCR.

Price of product ( USD price or FOB price) :
1no testing 20 USD

1kit testing = 96no testing

1kit = 96no * 24 USD = 2208 USD
(base on Qty negociable)

Product origin ;
korea

Key Specifications/Special Features :
1. with in 3hour testing result in come
2. One item 96person can check
3. 100% correct result coming then other method
4. It is same process in korea

Minimum Order Size and Packgaing details :
50kit in box
500 x 460 x350 6kg
MOQ : 500

Rapid test kit made in South Korea.

USD$18.00

AccuPowe COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 infections, detects SARS-CoV-2 (E gene and RdRp gene) RNA from a suspected infection patient's sample (such as sputum, nasopharyngeal swab, oropharyngeal swab) through Real-Time Polymerase chain reaction(PCR) using ExiStation Universal MDx system.

Validated to:
Bio-Rad CFX96
ABI 7500 Fast

Target Genes: Rdrp, E

Commodity: Covid-19 RT-PCR Detection Kit
Spec.96 tests/kit
Price:FOB SHANGHAI USD3.30/test, USD316.8/kit
$3.60/TEST CIF NY AIRPORT OR OTHER MAJOR AIRPORTS USA OR EUROPE OR S. AMERICA OR MIDDLE EAST
Payment: T/T ADVANCE 50% BALANCE BEFORE DEPARTURE OR Sight Irrevocable TRANSFERABLE LC Delivery: By AIR, 50days after receipt and confirmation of LC

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper
and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high
complexity tests.

This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and, 3. There is no adequate, approved, and available alternative to the emergency use of your
product.
4
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.

Sample Types :
Including Nasopharyngeal swab, Oropharyngeal swab, Sputum

Controls :
Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results

Product Information

Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.

Authorized Laboratories
Laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.

About Emergency Use Authorization
(EUA)
This test (1) has not been FDA cleared or approved, (2) has been authorized by
FDA under an EUA for use by authorized laboratories, (3) has been authorized
only for the detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.360bbb-3(b)(1), unless the authorization
is terminated or revoked sooner.

Product Description - COVID-19 Test Kit: ANTIBODY

Price of product ( USD price or FOB price) - Quantity dependent

Product origin - Switzerland

Key Specifications/Special Features - CE Mark: 96%/92% sensitivity; 100%/100% specificity (clinical). Approx. 10 minute result time

Minimum Order Size and Packaging details - 1000
10 per box, 100 box minimum

Product Description - COVID-19 Test Kit: ANTIGEN (s)

Price of product ( USD price or FOB price) - Quantity dependent

Product origin - Switzerland

Key Specifications/Special Features - CE Mark: 97.69% sensitivity; 99.9% specificity (clinical). Approx.10 minute result time

Minimum Order Size and Packaging details - 1000
25 per box, 40 box minimum

Product Description - COVID-19 Test Kit: ANTIGEN (n)

Price of product ( USD price or FOB price) - Quantity dependent

Product origin - Switzerland

Key Specifications/Special Features - CE Mark: 98% sensitivity; 99% specificity (clinical). Approx.10 minute result time

Minimum Order Size and Packaging details - 1000
25 per box, 40 box minimum

Product Description - COVID-19 Test Kit: PCR

Price of product ( USD price or FOB price) - Quantity dependent

Product origin - United States

Key Specifications/Special Features - FDA and CE: Dry swab: 97% sensitivity; 99% specificity. Lab processed


Minimum Order Size and Packaging details - 1000 25 per box, 40 box minimum

cDNA synthesis Kit
cDNA synthesis Kit with RNase inhibitor
OneStep RT-PCR Smart Mix

2X Real-Time PCR Master Mix including SYBR
Green in Mixture
2X HRM Master mix

Taq DNA Polymerase
Carmine Taq PCR Master Mix (With Dye)
2X Taq PCR Smart Mix without dye

The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal
aspirate) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C.
263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infective status. The agent detected may not be
the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The COVID-19 RT-PCR Detection Kit is intended for use by qualified trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization.

PRINCIPLE OF DETECTION
This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will
be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N
gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel.
dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products.
Internal reference is used in the kit for quality control starting from sample collection