FDA.reportPublic FDA data

DRG INSTRUMENTS GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028006973002800697DRG INSTRUMENTS GMBH1N2026-01-01FRAUENBERGSTRASSE 18 MARBURG Hesse DE D-35039

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3122911844315710K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITGGT2000-06-07
3122911718237483K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
3122911164078795K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODILYR1999-08-12
3122911837825546K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
3122911198018982K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
3122911981192628K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
3122911094667589K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
3122911473333970K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
3122911865068356K990207GLIADIN IGA ELISA TEST SYSTEMMST1999-03-26
3122911512197041K990204GLIADIN IGG ELISA TEST SYSTEMMST1999-03-26
3122911853215748K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITCKG1998-08-19
3122911520969667K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITJKR1998-09-03
3122911213042861K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISALSE1998-08-21
3122911517809052K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
3122911828661239K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
3122911298597984K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEMMID1998-06-02
3122911305262012K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
3122911345267818K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOB1998-02-17
3122911284518491K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISACEW1997-12-23
3122911464208310K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
3122911524653089K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
3122911574399046K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
3122911950310589K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
3122911523449830K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
3122911887696367K971709TOTAL THROXINE MICROPLATE EIA(225-300)KLI1997-06-16
3122912054454379K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYJIR1997-04-08
3122911945809967K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
3122911384287451K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
3122911332792791K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
3122911301914467K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
3122911700904223K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
3122911203831744K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
3122911451920647K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15
3122911716444402K962054ORGENTEC ANTI-SS-A(RO) ELISALJM1996-11-15
3122911218431540K962053ORGENTEC ANTI-JO-1 ELISALJM1996-11-15
3122911840540919K962052ORGENTEC ABTI-SS-BB(LA) ELISALJM1996-11-15
3122911172494774K961277RF IGM ELISA TEST SYSTEMDHR1996-05-08
3122911701489541K961012VZV IGG ELISA TEST SYSTEMLFY1996-07-24
3122911369369498K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMID1996-05-23
3122911351158357K955134ORGENTEC ENASCREEN ELISA ASSAYLLL1996-03-20
3122911858942604K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYLRM1995-11-09
3122911368573646K952130ORGENTEC ANTI-TG ELISAJZO1995-06-20
3122911928808001K952129ORGENTEC ANTI-TPO ELISAJZO1995-06-20
3122911482245827K944449EBV-VCA IGM ELISA TEST STSTEMLSE1995-09-25
3122911187966512K941409ENA PROFILE-6 ELISA TEST SYSTEMLJM1994-06-10
3122911821202624K941014ENA SCREEN ELISA TEST SYSTEMLJM1994-06-10
3122911147644725K940362ANA SCREEN ELISA TEST SYSTEMLLL1994-07-28
3122911646416513K933267AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEMLJM1993-12-15
3122911474583901K924096CMV ELISA TEST SYSTEMLFZ1993-04-02
3122911277196016K924091EBV-VCA IGG ELISA TEST SYSTEMMCD1993-01-11
3122912000568231K900196LYME IGM ELISA TEST SYSTEMLSR1990-05-02
3122911408376738K895292LYME IGG ELISA TEST SYSTEMLSR1989-12-13
3122911394826928K885317LYME ELISA TEST SYSTEMLSR1989-03-02
3122911467898272K780361T3 UPTAKE TESTKHQ1978-03-22
3122911913520666K181473DENV Detect NS1 ELISAQCU2018-08-27
3122911594606115K181017Free Testosterone AccuBind ELISA Test SystemCDZ2018-07-20
3122911583508558K12336425OH VITAMIN D TOTAL ELISA TESTMRG2013-07-15
3122911128362397K121046STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITPCG2012-12-20
3122911612119595K111650IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...JJX2011-09-06
3122911932698604K100499ORGENTEC RHEUMATOID FACTOR EIADHR2010-10-27
3122911836907627K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEJLX2008-01-29
3122911460864778K052649DRG SLV TESTOSTERONE ELISA TESTCDZ2006-01-27
3122911501269159K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAJLS2004-07-22
3122911583776759K040854WEST NILE VIRUS IGM CAPTURE ELISANOP2004-06-30
3122912062465044K032134TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KITJZO2003-09-10
3122911122255501K030929ANA DETECTLJM2003-05-02
3122911353001654K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300KLI2003-08-22
3122911470863467K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITCDZ2003-08-18
3122911870041238K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300CEC2002-04-05
3122911829976657K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119DCK2001-07-20
3122911455015515K001022BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061JZG2000-09-26
3122911712762688K000043DRG AURICA ELISA TESTOSTERONE KITCDZ2000-04-17
3122911069801686
3122911070714421
3122911098474761
3122911112233200
3122911117716930
3122911120596350
3122911122768731
3122911123301714
3122911132647196
3122911157231985
3122911164708359
3122911169040820
3122911176616871
3122911185510109
3122911195603899
3122911205324152
3122911215221711
3122911219387663
3122911222938225
3122911267567946
3122911281191203
3122911287416598
3122911291873395
3122911337619849
3122911338080465
3122911347929196
3122911358294103
3122911365762119
3122911372525745
3122911394757448
3122911406481164
3122911413831920
3122911452661435
3122911489777830
3122911501741044
3122911530847829
3122911537092454
3122911584958573
3122911585315260
3122911585552592
3122911596072103
3122911611600174
3122911689869113
3122911698372306
3122911700817837
3122911745542278
3122911755414162

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJM102003-05-02
MID61998-06-02
CDZ42018-07-20
MOB41998-02-17
JZO32003-09-10
KLI32003-08-22
JLW31999-06-22
LSR31990-05-02
DHR22010-10-27
DDC21999-06-25
CDP21999-06-02
MST21999-03-26
LSE21998-08-21
LLL21996-03-20
QCU12018-08-27
MRG12013-07-15
PCG12012-12-20
JJX12011-09-06
JLX12008-01-29
JLS12004-07-22
NOP12004-06-30
CEC12002-04-05
DCK12001-07-20
JZG12000-09-26
GGT12000-06-07
DGC11999-09-21
LYR11999-08-12
JKR11998-09-03
CKG11998-08-19
CEW11997-12-23
CGJ11997-09-02
JNL11997-07-03
JIR11997-04-08
LFY11996-07-24
LRM11995-11-09
LFZ11993-04-02
MCD11993-01-11
KHQ11978-03-22