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GOLD STANDARD DIAGNOSTICS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072082593007208259GOLD STANDARD DIAGNOSTICS, LLC1Y2026-01-012795 2nd St Ste 300 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
868211435588108
868211912289698
868211036499083
868211278369175
868211286147792
868211288322253
868211368832673
868211404312155
868211719536723
868211785982682
868211928622824
868212003375895

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