Replies to post #106751 on Arrayit Corporation (ARYC)

[Sloan89RH]

Also agree that the total cost to manufacture could have been much less.

[TravO]

Yes they actually make so much money they were questioned......

[StockDetective]

Arrayit Corporation Ships Clinical Instrumentation and Software to the United States Food and Drug Administration

Sunnyvale, Sept. 24, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, reports the shipment of clinical instrumentation and quantification software to the United States Food and Drug Administration (FDA). Arrayit uses the same instrumentation and software to test for allergy and food intolerance as well as pipeline indications for ovarian cancer and Parkinson’s Disease (PD). Testing is performed in the company’s Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the California Department of Public Health (CDPH) and the Center for Medicare and Medicaid Services (CMS).

http://arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/Arrayit_Corporation_Ships_Clin/arrayit_corporation_ships_clinical_instrumentation_and_software_.html


1-2-18: Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance https://www.fda.gov


Market’s first high-performance blood card technology... Blood card technology is pending 510(k) submission and is not to be used for in vitro diagnostics prior to FDA approval.

http://www.arrayit.com/Microarray_Diagnostics/Blood_Cards/blood_cards.html



510(k) Clearance to Market:

The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.

Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.

http://www.qrasupport.com/FDA_MED_DEVICE.


1-3-18 Arrayit advanced microarray technology to be incorporated into a clinical trial by a major pharmaceutical giant in a development that could significantly increase revenues and earnings in 2018 arrayit.com/Products/products.html



Kaiser Permanente?
5/11/18: Arrayit prototyping team completes custom whole blood collection card for $64.6 billion health maintenance organization HMO leader Kaiser Permanente headquartered in Oakland California USA and providing premium healthcare to 11,700,000 members in 8 states (link: https://healthy.kaiserpermanente.org) healthy.kaiserpermanente.org



5/25/2018: Arrayit CLIA clinical team completes allergy testing sample collection kits for health maintenance organization (HMO) giant Kaiser Permanente headquartered in Oakland California USA and providing premium healthcare for 11.7 million health plan members (link: https://healthy.kaiserpermanente.org) healthy.kaiserpermanente.org


5/29/2018: Arrayit CLIA clinical team delivers complimentary wellness test kits and requisition forms to the nation's leading health maintenance organization HMO Kaiser Permanente HQ in Oakland California USA and providing premium healthcare to 11.1 million members (link: https://healthy.kaiserpermanente.org) healthy.kaiserpermanente.org



5/31/2018: Arrayit CLIA clinical team schedules follow up visit regarding allergy testing with the world's largest health maintenance organization HMO Kaiser Permanente headquartered in Oakland California USA and providing premium healthcare to 11,100,000 patients (link: https://healthy.kaiserpermanente.org) healthy.kaiserpermanente.org



6/14/2018: Arrayit CLIA clinical team submits Client Services Manual to $64.6 billion health maintenance organization HMO leader Kaiser Permanente headquartered in Oakland California USA and providing premium healthcare services and care for 11.7 million patients (link: https://healthy.kaiserpermanente.org) healthy.kaiserpermanente.org


10/24/2018: Arrayit CLIA clinical team reports scheduled sales visit today to present finger allergy microarray testing to top officials at prestigious Kaiser Permanente headquartered in Oakland California USA and providing premium healthcare to 11.7 million members (link: https://healthy.kaiserpermanente.org) healthy.kaiserpermanente.org


https://mobile.twitter.com/arrayit/status/994975187224346624/photo/1


Arrayit private labeling Blood Card technology is pending 510(k) approval by the FDA.


http://www.arrayit.com/Microarray_Diagnostics/Blood_Cards/blood_cards.html