CLIA Waived
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 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
EUA Authorized
Gives Positive or Negative Result for COVID-19 virus
Read Results in 15 Minutes
24 Month Expiration from Date of Manufacture
Contents
20 Test Devices
20 Disposable Pipettes
20 Alcohol Prep Pads
Sterile Safety Lancets
Buffer
Package Insert
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains: GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request. To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away. 1. Nasopharyngeal 2. Nasal 3. Saliva Price and Minumum Quantity Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet Sample: Available. Sample Cost Born By Supplier Product Model And Origin Brand: GENEDIAModel: 643G-S (Saliva) Seller Code: Genedia w covid 19 agHS Code: 3002.15 Standards: Ce Competitive Advantages Allow wider testing with fast test time (10 minutes) All necessary materials provided / no equipment needed Sensitivity: 93.33%, specificity: 100% Free sample. no moq. price is negotiable. customized packing. Other Details 20 tests / kit 24 months from the date of manufacture 2 ~ 30c(35.6 ~ 86f) available for room temperature deliver In stock. fast delivery. 1 x Instructions for Use Manual 40 x Test Cassettes 1 x Buffer 40 x Dropper
Angiten-COVID-19 Virus Test Kit (Colloidal Gold) Quantity of box: 25 persons/box Brand: Easysweet NMPA (National Medical Products Administration): Approved CE: with CE mark BfArM: listed Test Method: Antigen Test Result Time: 10-15 mins Sample Type: Nasal Swab Sensitivity: 96.70% Specificity: 100% Accuracy: 98.94% Shelf Life: 24 months Storage Temperature: 2-30 Degree Celsius Country of Origin: Made in China Additional Information: Production Capacity: 1 million Delivery Time: 10-15 days Packaging Details: 25 tests in a pack, 40packs/ carton Angiten-COVID-19 Virus Test Kit is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. It can be used by professional only. Price and Minumum Quantity Price FOB in USD: NegotiableMinimum Order Qty: 10000 Production Capacity: 1000000Packaging: 25 Persons/box Sample: Available. Sample Cost Born By Buyer Product Model And Origin Brand: Easysweet HS Code: 3822009020 Standards: Ce Competitive Advantages Best price with shortest delivery time Best price with shortest delivery time Best price with shortest delivery time Best price with shortest delivery time Other Details Angiten-covid-19 virus test kit (colloidal gold) Angiten-covid-19 virus test kit (colloidal gold) Angiten-covid-19 virus test kit (colloidal gold) Angiten-covid-19 virus test kit (colloidal gold)
Covd-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and dierential detection of IgG and IgM antibodies to 2019 Novel Corona Virus in human whole blood, serum or plasma. Specification.jpg Product: Rapid Diagnostic Test Kit Item: Corona Virus Test Kit Specimen: Whole Blood/Serum/Plasma Format: Strip/Cassette Port of Loading: Shanghai OEM and ODM: OEM/ODM Welcome Shipping: By UPS, FEDEX, DHL, TNT, by air or by sea MOQ for Private label: Low MOQ 1600 boxes, Please contact us. Note: Store this product in a cool and dry place, avoid direct sunlight, stay away from places that children can contact, and avoid eye contact. If you have allergies to this product, please stop using and consult a doctor. COVID-19 Corona Virus Rapid Test Kit11.pngCOVID-19 Corona Virus Rapid Test Kit12.png
Access Bio Care Start Covid-19 Rapid Antigen Test Kit Product Details: Number of Reactions(Preps) per Kit : 1 Brand : Access Bio Test Method : Antigen Test Result Time (Rapid Kits) : 10 min Sample Type ; Nasal Swab Packaging Size : 20 Test Kits/Box Packaging Type : Box 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 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
FAST: Results in under 2 minutes ACCURATE: 99.9% specificity and 98.7% sensitivity EASY TO USE: Convenient for testing at home PAINLESS: Simple and painless saliva collection RELIABLE: 24-Hour RT-PCR Confirmation (100% specific and 100% sensitive) 99.9% specificity. Test specificity this high ensures that almost all the people who are not infected get a negative test result with the Sensiva React Rapid Covid-19 Testing Kit. Using a fast and accurate test such as this one is vital when we are trying to stop virus transmission and protect general health. 98.7% sensitivity Test sensitivity refers to the percentage of infected people who get a positive test result. In our case that means that 98.7% of people with an infection get a positive test result. How to use it? Step 1 â?? Do the test Sensiva React Rapid Test is a simple test that can be� easily done at home. It is convenient and� painless� since it requires you to collect a saliva sample instead of a nasal swab. How to do it? First, use the mobile application to scan the QR code to register. After that, collect a saliva sample and add it into the saliva hole in the reader device before adding the liquid solution. You will be able to interpret your� results in under 2 minutes. Watch a video with detailed instructions on how to do the test in the video below. Please follow the instructions carefully to obtain a valid test result. Step 2 â?? Get RT-PCR confirmation in 24 hours You can use the prepaid shipping label and send the saliva sample used for the rapid test to us. You will get an official PCR result (100% sensitivity and 100% specificity) in 24 hours. Our lab is certified under the Clinical Laboratory Improvement Amendments (CLIA), so you can rely on us to provide you with accurate and reliable test results. Who is Sensiva React Rapid Covid-19 Test for? Sensiva React Rapid Covid-19 Test is designed for patients with COVID-19 symptoms or those who are asymptomatic but suspected of having exposure. Its easy-to-follow instructions make it convenient for testing at home. The kit contains: (1) Specimen Tube (1) Saliva Funnel (1) Dropper (1) Bio-hazard bag with absorbent pad (1) Lateral flow device (1) 5ml EZ-Tear Saline Solution (1) 0.3ml EZ-Tear Buffer Solution (1) Written Instruction Card