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Tuesday, 09/25/2018 1:46:47 PM

Tuesday, September 25, 2018 1:46:47 PM

Post# of 205136
Huge ARYC list of business acting...MASSIVE


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



AllergyPro?
http://www.labpharmllc.com/emailblast/allergy.html

“our comprehensive Allergy Program Offering, Including Allergy Labs of America, Allergy-Pro and the New Finger Stick Blood Drop Allergy Cards. The bulk of the call will also be discussing 2 new Lab Partners that we have recently added to our network.”


https://s3.amazonaws.com/bbemail/PROD/ulib/p5d1n/docs/73d0e7a8-72f3-5203-445b-dfea5f12a989/HMAllergyProSales11.12.16.pdf


AllergyPro/AllergyGo Website Disclaimer:

The services on this website are provided by ARRAYIT CORPORATION, a Nevada corporation (“Arrayit”) and ALLERGYGO, LLC, a Texas limited liability company (“AllergyGo”). Arrayit is in the business of developing and manufacturing certain proprietary life science technologies for disease prevention and treatment, specifically including advanced blood card technology with IgE microarray testing for allergens (“Tests”), and AllergyGo is in the business of marketing and distributing allergy testing products.

http://allergygo.com/




Arrayit recently completed an allergy testing pilot program for a top retail chain, established a nationwide network of 1,700 allergy sales professionals, met with top officials at the United States Food and Drug Administration (FDA) regarding FDA approval of a major product line, reported the sale of clinical instrumentation to the FDA, signed allergy testing contracts with a consortium of 178 medical clinics and received approval for in-store promotions by a major retailer. Arrayit’s new therapeutics partners provide a seamless solution to doctors who diagnose and treat the more than 50 million Americans reporting allergic symptoms annually.

http://www.arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/Arrayit_Corporation_Announces_/arrayit_corporation_announces_allergy_testing_partnerships_with_.html




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.html



9-24-18 Arrayit Corporation Ships Clinical Instrumentation and Software to the United States Food and Drug Administration

https://www.yahoo.com/amphtml/finance/news/arrayit-corporation-ships-clinical-instrumentation-093000351.html



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


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


Kaiser Permanente laboratories and Quest Diagnostics Inc.(Quest) provide all outpatient laboratory services for members in the KPMAS Service Area.

http://providers.kaiserpermanente.org/info_assets/cpp_mas/mas_provman_ch11.pdf


Quest Diagnostics partnership?

https://questallergy.com/

https://www.questdiagnostics.com/home/patients/scheduling-test/food-and-drug-retail-locations.html


“Fingerstick Screenings from Quest Diagnostics Health & Wellness”
http://www.questforhealth.com/resources/product-overviews/fingerstick-screenings-quest-diagnostics-health-wellness/