FDA.reportPublic FDA data

MORE DIAGNOSTICS INC.

Matched from indexed company URL: MORE DIAGNOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20850851000142648MORE DIAGNOSTICS INC.1N2026-01-012020 11TH ST Los Osos CA US 93402

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00856743007000Whole Blood Matrix - MORE DIAGNOSTICS Whole Blood Matrix is intended to be used as a whole blood matrix and zero level control product to check calibration in chemistry analyzers which measure everolimus, rapamycin (sirolimus), tacrolimus, and cyclosporine.800-758-0978info@morediagnostics.com
00856743007116Whole Blood Matrix - MORE DIAGNOSTICS Whole Blood Matrix is intended to be used as a whole blood matrix and zero level control product to check calibration in chemistry analyzers which measure everolimus, rapamycin (sirolimus), tacrolimus, and cyclosporine.800-758-0978info@morediagnostics.com
00856743007222Rap/Tac/CsA Control - MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine.18007580978info@morediagnostics.com
00856743007239Rap/Tac/CsA Control - MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine.18007580978info@morediagnostics.com
00856743007277EV/TAC/CsA Control - MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.800-758-0978info@morediagnostics.com
00856743007284EV/TAC/CsA Control - MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.800-758-0978info@morediagnostics.com
00856743007291EV/TAC/CsA Control - MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.800-758-0978info@morediagnostics.com
00856743007307EV/TAC/CsA Control - MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.800-758-0978info@morediagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
485461442844921K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SDIF1998-03-16
485461298074449K972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELJJT1997-08-29
485461246169263K932662CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVELLAS1993-07-26
485461202187558K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELLAS2008-01-30
485461713197228K050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4JJY2005-03-18
485461298378768
485461718521429

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LAS22008-01-30
JJY12005-03-18
DIF11998-03-16
JJT11997-08-29

PMN#

GUDID#