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.
From as little as $1.00 FoB per test - including IFU in Language of your choice!
COVID Rapid Test / Lateral Flow
- SARS-CoV-2 Antigen Kit Self Test Kit
- Nasal Swab based
- Qualitative
- IVD (Invitro diagnostic medical device)
- Rapid immunochromatographic assay
- 12 Minutes to result
- Shelf Life 18 months
- EU common list approved.
- In use: BE, BG, CY, FR, RO, SI, ES
- Validation Completed:
- FR, DE, ES
UK DHSC Approved.
- Validation completed & In use
- Specificity 100.0%
- Sensitivity 93.0%
Certifications:
EU HSC Approved
UK DHSC Approved
(included in JRC database)
CE
Directive 98/79/EC
EN ISO 13485:2016
BS EN 13612:2002
ISO 14971:2019
EN ISO 23640:2015
ISO 15223-1:2016
EN ISO 18113-1:2011
EN ISO 18113-4:2011
EN 62366-1:2015
More Information is available at our website.
Please contact us directly, visit our website, follow us on LinkedIn and/or Instagram.
@fiigureofficial
in = fiigureofficial
Great for Kids.
From as little as $1.00 FoB per test - including IFU in Language of your choice!
COVID Rapid Test / Lateral Flow
- SARS-CoV-2 Antigen Kit Self Test Kit
- Saliva based - Lollipop Style
- Qualitative
- IVD (Invitro diagnostic medical device)
- Rapid immunochromatographic assay
- 15 Minutes test to result
- Shelf Life 18 months
- EU common list approved.
- In use: BE, BG, CY, FR, RO, SI, ES
- Validation Completed:
- FR, DE, ES
UK DHSC Approved.
- Validation completed & In use
- Specificity 100.0%
- Sensitivity 93.0%
Certifications:
EU HSC Approved
UK DHSC Approved
(included in JRC database)
CE
Directive 98/79/EC
EN ISO 13485:2016
BS EN 13612:2002
ISO 14971:2019
EN ISO 23640:2015
ISO 15223-1:2016
EN ISO 18113-1:2011
EN ISO 18113-4:2011
EN 62366-1:2015
More Information is available at our website.
Please contact us directly, visit our website, follow us on LinkedIn and/or Instagram.
@fiigureofficial
in = fiigureofficial
o Product Name
- Gendbody COVID-19 AG Test Kit
- Gendbody COVID-19 AG Home Test Kit
- Gendbody COVID-19 lgG/lgM
o Price (USD) : 2.5$ (FOB) - Can be discussed up to order Qty
- CIF : Can be discussed
o Certification : CE,FDA
o MOQ : 1,000 pcs
o Payment : L/C, TT
o Delivery Time
- Up to Qty
- Capacity : 3,000,000pcs / 1week
Genbody Covid-19 AG Home Test Kit is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein from SARS-COV-2 from individual's nasal specimen with or without COVID-19 symptoms.
933 Covid 19 Detection Kit Suppliers
Short on time? Let Covid 19 Detection Kit sellers contact you.
* High Accuracy, Specificity and Sensitivity
* No need instrument, Get Results in 15 Minutes
* Room Temperature Storage
* Sample: Saliva Sample
* Detect the presence of viral proteins
* Identify acute or early infection
1 Test/Kit
***** WE ARE THE AUTHORIZED DISTRIBUTOR IN MALAYSIA ******
***** WELCOME RESELLERS ******
COVID-19 IgM/IgG Antibody Detection Kit (Colloidal Gold Immunochromatography) is suitable for the qualitative detection of COVID-19 by detecting SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. SARS-CoV-2 can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets
Due to contractual obligations to the federal government, Current suppliers have increased costs and limited production of all point of care tests without notice. We have great news! To shield our customers from excessive price increases as well as provide immediate availability, we have secured multiple FDA EUA rapid antigen test kit options. These tests have similar and/or better accuracy along with individual buffer bottles. We are currently able to provide three options: Clarity-Sienna, Indicaid and Celltrion DiaTrust kits. We work directly with the distributor and can supply by the pallet or case with pricing as low as $6.00 per kit.
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The CLIA Waived COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.
Indication:
Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
About Test Device
EUA Authorized
CE Mark
Test does NOT give positive or negative result for COVID-19 virus. This is an antibody test, it only indicates past or recent infection.
Read Results in 15 Minutes
9 Month Expiration from Date of Manufacture
Contents
The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Lateral flow assay
Detect SARS-CoV-2 nucleocapsid protein antigen
Rapid results within 10-15 minutes
Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only
For use with direct anterior nasal and nasopharyngeal swab specimens
Clinical Performance
93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
87.18% PPAa and 100% NPAb when used with anterior nasal swab
The COVID-19 IgG/IgM Rapid Test Device is an in vitro Immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.
Indication:
Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
About Test Device
Gives Positive or Negative Result for COVID-19 IgM/IgG antibodies
Read Results in 15 Minutes
Contents of each box
We, CentZone, are proudly offer you COVID-19 Self-Test Kit as below.
Required document must be submitted in order to provide detail information of each Test Kits.
Otherwise no information will be available.
If you are willing to order and purchase below COVID-19 Self-Test Kits, please do send below information in LOI contract by return at oversea@centzone.co.kr
[Required Documents]
* LOI Contract
- LOI contract must include below information as a mandatory
- Local sales company information including Tel, Address, E-mail, Website, Business Registration Number and name of the person in charge.
- Company Profile for both broker and end-sales company.
- Yearly Forecast Volume
[COVID-19 SELF-TEST KIT PRODUCT]
1. Genbody COVID-19 Self-Check Kit
*FDA Certificates.
(1) Professional Use : MOQ 100,000 Kits
$5.00/Kit --> 25 Kits per Set
(2) Home Use : MOQ 100,000 Kits
$6.00/Kit --> 2 Kits per Set
2. Celltrion COVID-19 Self-Check Kit
*FDA Certiticates.
(1) Home Use : MOQ : 100,000 Kits
$8.00/Kit --> 2 Kits per Set
3. G-Mate(Filosys) Saliva COVID-19 Self-Test Kit
* Accuracy : +98%
* MOQ : 1,000,000 Kits
(1) $3.0 / Kit : 25 test kits per box
(2) $3.2 / kit : 1 test kit per box
4. ND Force Saliva COVID-19 Self-Test Kit
* Accuracy : ±94%
* Recently approved by German FDA.
* CFS(Certificates of Free Sales) can be provided direcctly from German FDA.
* 1 Kit per Set.
- MOQ 100,000 Kits : U$2.60
- MOQ: 500,000 Kits : U$2.50
- MOQ: 1,000,000 Kits : U$2.30
STANDARD M nCoV Real-Time Detection kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples.
- One tube reaction for identification and detection of 2019-nCoV
- One-step Real-Time RT-PCR
- Provide all reagents required for PCR
- Designed according to WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans"
- nCoV primers/probes ORF1ab (RdRp) gene, E gene
Provide Internal controls
Kindly check ghope-ppe.com. All information is for a consumer. If you want to buy a bulk, please contact us.
The n-FasT SARS-CoV-2 diagnostic kit, has the Lamp method, which is among the most reliable detection methods. The reaction that reveals the diagnosis result for Covid-19 in a fast, practical and safe way yields results with a colorimetric method based on colour change. n-FasT differs from all other kits with the opportunity to give results below the patient within 30 minutes in application and with 97 % success rate result interpretation.
Origin: Korea
Certification: USA FDA EUA Approved, WHO Compliant, CE approved
Validated to: Bio-Rad CFX96,ABI 7500 Fast
Target Genes: Rdrp, E, N
Weekly Production cap: 1,000,000
MOQ: 100,000 tests (1000 kits)
Cost: $20 USD FOB
* Special D/C price: $17.00 USD test
933 Covid 19 Detection Kit Suppliers
Short on time? Let Covid 19 Detection Kit sellers contact you.
