FDA.reportPublic FDA data

D.R.G.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22452852245285DRG International, Inc.1Y2026-01-01841 Mountain Ave Springfield NJ US 07081
30028006973002800697DRG INSTRUMENTS GMBH1N2026-01-01FRAUENBERGSTRASSE 18 MARBURG Hesse DE D-35039
30065511573006551157DRGEM CORPORATION1N2026-01-017F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro Gwangmyeong-si Gyeongbuk KR 14322
30240828153024082815DRGEM AMERICA INC1Y2026-01-0113755 HUTTON DR Suite 500 Farmers Branch TX US 75234
22452852245285DRG International, Inc.1Y2020-04-25841 Mountain Ave Springfield NJ US 07081
30096705723009670572DRGEM USA INC1Y2020-04-257018 NW 50th Ter Gainesville FL US 32653

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
65951674470599K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITGGT2000-06-07
3122911844315710K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITGGT2000-06-07
3122921844315710K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITGGT2000-06-07
65951687577731K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
3122911718237483K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
3122921718237483K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
65951611280537K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
65951087006254K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODILYR1999-08-12
3122911164078795K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODILYR1999-08-12
3122921164078795K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODILYR1999-08-12
65951034077572K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
65951201944850K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
3122911837825546K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
3122921837825546K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
3122911198018982K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
3122921198018982K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
65951853832091K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
65951168999622K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
3122911981192628K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
3122921981192628K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
65951109661196K991179ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMDDC1999-06-17
3122911094667589K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
3122921094667589K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
65951802647251K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
3122911473333970K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
3122921473333970K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
65951476425604K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
65951909312204K990249OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031CEP1999-03-22
65951208392113K990207GLIADIN IGA ELISA TEST SYSTEMMST1999-03-26
3122911865068356K990207GLIADIN IGA ELISA TEST SYSTEMMST1999-03-26
3122921865068356K990207GLIADIN IGA ELISA TEST SYSTEMMST1999-03-26
3122911512197041K990204GLIADIN IGG ELISA TEST SYSTEMMST1999-03-26
3122921512197041K990204GLIADIN IGG ELISA TEST SYSTEMMST1999-03-26
65951541439229K990204GLIADIN IGG ELISA TEST SYSTEMMST1999-03-26
65951854180110K983656HSV-1 AND/OR -2 IGM ELISA TEST SYSTEMLGC1999-03-18
65951788076987K982938QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153DJR1999-02-05
65951106092354K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITCKG1998-08-19
3122911853215748K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITCKG1998-08-19
3122921853215748K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITCKG1998-08-19
65951209762840K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITJKR1998-09-03
3122911520969667K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITJKR1998-09-03
3122921520969667K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITJKR1998-09-03
65951828179231K982152QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152DIS1998-09-21
65951837405709K981687QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1JXM1998-06-03
3122911213042861K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISALSE1998-08-21
3122921213042861K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISALSE1998-08-21
65951525316155K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISALSE1998-08-21
65951399030756K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
3122911517809052K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
3122921517809052K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
65951424112774K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
3122911828661239K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
3122921828661239K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
3122911298597984K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEMMID1998-06-02
3122921298597984K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEMMID1998-06-02
65951372480970K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEMMID1998-06-02
65951034643072K980865QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131DKZ1998-04-01
65951663749349K980638ADI SYPHILIS RPR LIQUID CONTROLSGMP1998-07-06
65951990634756K980532QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012LCX1998-03-11
3122911305262012K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
3122921305262012K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
65951763260373K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
3122911345267818K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOB1998-02-17
3122921345267818K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOB1998-02-17
65951865012900K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOB1998-02-17
65951025236875K974615QUICKSTICK PRO HCG TESTJHI1998-01-26
65951365894072K974582QUICKSCREEN ONE STEP PCP SCREENING TESTLCM1998-02-04
3122911284518491K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISACEW1997-12-23
3122921284518491K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISACEW1997-12-23
65951439425709K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISACEW1997-12-23
65951869652675K973570QUICK CARD HCG ONE STEP PREGNANCY TESTLCX1997-10-31
65951614113666K973122QUICKSCREEN ONE STEP THC SCREENING TESTLDJ1997-09-25
3122911464208310K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
3122921464208310K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
65951505597719K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
65951975584746K972619QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)DJG1997-08-20
65951247926989K972618QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)DMN1997-08-08
65952038182795K972577QUICK SCREEN ONE STEP AMPHETAMINE TESTDIT1997-08-20
65951226049263K972556QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)LAF1997-09-02
65951478873883K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
3122911524653089K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
3122921524653089K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
3122911574399046K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
3122921574399046K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
65951812260386K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
65951723246338K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
3122911950310589K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
3122921950310589K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
65951352550510K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
3122911523449830K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
3122921523449830K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
65951385404776K971709TOTAL THROXINE MICROPLATE EIA(225-300)KLI1997-06-16
3122911887696367K971709TOTAL THROXINE MICROPLATE EIA(225-300)KLI1997-06-16
3122921887696367K971709TOTAL THROXINE MICROPLATE EIA(225-300)KLI1997-06-16
65951240686586K971503MYCOPLASMA IGM ELISA TEST SYSTEMLJZ1997-08-20
65951333986147K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYJIR1997-04-08
3122912054454379K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYJIR1997-04-08
3122922054454379K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYJIR1997-04-08
65951188772286K970150MYCOPLASMA IGG ELISA TEST SYSTEMLJZ1997-06-16
65952046775072K970149LEGIONELLA ELISA TEST SYSTEMLHL1997-06-18
65951833689308K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
3122911945809967K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
3122921945809967K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
3122911384287451K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
3122921384287451K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
65951999937312K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
3122911332792791K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
3122921332792791K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
65951771884232K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
65951253462025K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
3122911301914467K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
3122921301914467K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
3122911700904223K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
3122921700904223K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
65952027220665K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
3122911203831744K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
3122921203831744K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
65951433086398K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
3122911451920647K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15
3122921451920647K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJM302003-05-02
MID191998-06-02
MOB132004-04-05
CDZ122018-07-20
JLW101999-06-22
KLI92003-08-22
LSR91990-05-02
KPR82025-01-07
JZO82003-09-10
DDC81999-06-25
IZL72026-05-14
DHR62010-10-27
CDP61999-06-02
MST61999-03-26
LSE61998-08-21
LLL61996-03-20
NOP52004-11-19
MRG42013-07-15
JJX42011-09-06
CGJ42005-11-30
LFZ41993-04-02
QCU32018-08-27
PCG32012-12-20
JLX32008-01-29
JLS32004-07-22
CEC32002-04-05
DCK32001-07-20
JZG32000-09-26
GGT32000-06-07
DGC31999-09-21
LYR31999-08-12
JKR31998-09-03
CKG31998-08-19
CEW31997-12-23
JNL31997-07-03
JIR31997-04-08
LFY31996-07-24
LRM31995-11-09
MCD31993-01-11
KHQ31978-03-22

PMN#

PROMO

2025-08-22

DRGEM Corporation