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GOLD STANDARD DIAGNOSTICS, LLC

Matched from indexed company URL: Gold Standard Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072082593007208259GOLD STANDARD DIAGNOSTICS, LLC1Y2026-01-012795 2nd St Ste 300 Davis CA US 95618
30081912453008191245Gold Standard Diagnostics Frankfurt GmbH1N2026-01-01Waldstrasse 23 A6 Dietzenbach Hesse DE 63128
30139441363013944136GOLD STANDARD DIAGNOSTICS1N2020-04-25628 Cantrill Drive Davis CA US 95618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
868211590882274K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMLRM2000-02-18
868212052588338K993294DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEMLKJ1999-10-25
868211926374141K991274MUMPS IGG ELISA TEST SYSTEMLJY1999-09-03
868211701008687K984228IS ANTI-TPO IGG ELISA TEST SYSTEMJZO1999-02-02
868211778601910K983740IS-ANTI-PR3 IGG ELISA TEST SYSTEMMOB1998-11-18
868211750231849K983553ANTI-TG IGG ELISA TEST SYSTEMJZO1998-12-07
868211010976450K983390IS-ANTI-MPO IGG ELISA TEST SYSTEMMOB1998-11-18
868211378876817K982352VCA IGM ELISA TEST SYSTEMLSE1998-11-25
868212003519840K982350EA-D IGM ELISA TEST SYSTEMLSE1998-11-25
868211446559942K982348EBNA-1 IGM ELISA TEST SYSTEMLSE1998-11-25
868211694024995K981867IS-VZU IGG TEST SYSTEMLFY1998-09-28
868212054968267K981831IS EBV-EA-D IGG ELISA TEST SYSTEMGNP1999-02-16
868211057981419K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMGNP1999-02-16
868212068412764K981812EBV-VCA IGG ELISA TEST SYSTEMLSE1999-03-04
868211411914969K981729IS-RUBELLA IGG TEST SYSTEMLFX1999-01-28
868211539161621K981498IS-TOXOPLASMA IGG TEST SYSTEMLGD1998-08-21
868211100246445K981306DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEMLGC1998-09-29
868211986869394K981163DIAMEDIX IS-CMV IGG TEST SYSTEMLFZ1998-09-21
868211223516701K980059SERAQUEST MUMPS IGGLJY1998-04-23
868211318681296K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMLJB1998-01-28
868211268111086K972295SERAQUEST VZV IGGLFY1997-11-05
868211645623967K971672SERAQUEST TOXOPLASMA IGMLGD1997-10-21
868211547104453K970239IS-ANTI-SCL-70 TEST SYSTEM (720-280)LLL1997-04-08
868211347537306K970238IS-ANTI-SM/RNP (720-270)LLL1997-04-08
868211162259169K970237IS-ANTI-SSB TEST SYSTEM (720-260)LLL1997-04-08
868211543915969K970228IS-ANTI-JO-1 TEST SYSTEMLLL1997-04-08
868211329507594K970220IS-ANTI-SM TEST SYSTEMLLL1997-04-08
868211820616439K970218IS-ANTI-SSA TEST SYSTEMLLL1997-04-08
868211047543819K961053SERAQUEST RUBELLA IGGLFX1996-09-04
868211124093574K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
868211524712524K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
868211941121408K954191SERAQUEST CMV IGGLFZ1996-02-23
868211119103154K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ2025-10-10
868211208849351K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR2021-03-22
868211959520738K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR2021-03-22
868211585689879K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR2021-03-22
868211029752604K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR2021-03-22
868211475309705K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR2020-04-06
868211173321243K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR2020-04-06
868211373794636K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR2018-05-02
868211433920846K162276SeraQuest Herpes Type 1 Specific IgGMXJ2016-10-01
868212031910333K152353SeraQuest HSV Type 2 Specific IgGMYF2016-05-13
868211135356898K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ2015-11-12
868211900743624K131330GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITLJM2014-01-28
868211515328545K113847BORRELIA BURGDORFERI IGG BLOT TESTLSR2012-04-11
868211074595395K113846BORRELIA BURGDORFERI IGM BLOT TESTLSR2012-06-01
868211261014658K110899GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITLYR2012-02-01
868211414337008K110745HELICOBACTER PYLORI ELISA IGG TEST KITLYR2012-03-02
868211527397023K050590ENZY-WELL SYPHILIS IGG, MODEL 91106LIP2006-08-10
868212003285589K021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMDHR2002-07-09
868211981302949K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMLGC2000-11-28
2110111036499083
868211435588108
868211912289698
1119741001412911
868211036499083
1119741074091631
1119741160367024
1119741176928658
1119741205812023
1119741260473605
868211278369175
1119741282781632
1119741284404584
868211286147792
868211288322253
1119741313169514
1119741326290310
1119741358391568
1119741360491045
868211368832673
868211404312155
1119741411047785
1119741479471673
1119741543961195
1119741559374006
1119741560057798
1119741574822618
868211719536723
1119741768301126
1119741771974945
1119741781807148
868211785982682
1119741859003796
1119741873662137
868211928622824
1119741967116100
1119741973462581
1119741982766336
868212003375895
1119742067239147

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LSR92021-03-22
LLL61997-04-08
LSE41999-03-04
LGD31998-08-21
GMQ22025-10-10
LYR22012-03-02
LGC22000-11-28
LKJ21999-10-25
LJY21999-09-03
GNP21999-02-16
JZO21999-02-02
LFX21999-01-28
MOB21998-11-18
LFY21998-09-28
LFZ21998-09-21
MXJ12016-10-01
MYF12016-05-13
LJM12014-01-28
LIP12006-08-10
DHR12002-07-09
LRM12000-02-18
LJB11998-01-28

PMN#

GUDID#

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