FDA.reportPublic FDA data

DRG International, Inc.

Matched from indexed company URL: DRG International Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22452852245285DRG International, Inc.1Y2026-01-01841 Mountain Ave Springfield NJ US 07081
22452852245285DRG International, Inc.1Y2020-04-25841 Mountain Ave Springfield NJ US 07081

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
00840239027733ANA Screen IgG ELISA - The ANA Screen ELISA test system is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to the enclosed instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns.9735647555corpoffice@drg-international.com
00840239035622ANA-8-Screen ELISA - ANA-8-Screen ELISA is a test system for the qualitative measurement of antinuclear antibodies (ANAs) SS-A (52 and 60 kDA), SS-B, RNP-70, Sm, RNP/Sm, Scl-70, Centromere B and Jo-1 in human serum or plasma.9735647555corpoffice@drg-international.com

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
3122921844315710K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITGGT2000-06-07
65951687577731K992528BIOCHECK 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
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
3122921837825546K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
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
3122921981192628K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
65951109661196K991179ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMDDC1999-06-17
3122921094667589K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
65951802647251K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
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
3122921865068356K990207GLIADIN IGA 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
3122921853215748K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITCKG1998-08-19
65951209762840K982491SANGUI 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
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
3122921517809052K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
65951424112774K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
3122921828661239K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
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
3122921305262012K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
65951763260373K974702ORGENTEC ANTI-PR3 (C-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
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
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
3122921524653089K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
3122921574399046K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
65951812260386K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
65951723246338K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
3122921950310589K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
65951352550510K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
3122921523449830K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
65951385404776K971709TOTAL 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
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
3122921945809967K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
3122921384287451K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
65951999937312K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
3122921332792791K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
65951771884232K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
65951253462025K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
3122921301914467K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
3122921700904223K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
65952027220665K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
3122921203831744K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
65951433086398K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
3122921451920647K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15
65951925271307K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15
65951285456039K962054ORGENTEC ANTI-SS-A(RO) ELISALJM1996-11-15
3122921716444402K962054ORGENTEC ANTI-SS-A(RO) ELISALJM1996-11-15
3122921218431540K962053ORGENTEC ANTI-JO-1 ELISALJM1996-11-15
65951727039563K962053ORGENTEC ANTI-JO-1 ELISALJM1996-11-15
3122921840540919K962052ORGENTEC ABTI-SS-BB(LA) ELISALJM1996-11-15
65951987150551K962052ORGENTEC ABTI-SS-BB(LA) ELISALJM1996-11-15
3122921172494774K961277RF IGM ELISA TEST SYSTEMDHR1996-05-08
65951981538524K961277RF IGM ELISA TEST SYSTEMDHR1996-05-08
65951423539511K961012VZV IGG ELISA TEST SYSTEMLFY1996-07-24
3122921701489541K961012VZV IGG ELISA TEST SYSTEMLFY1996-07-24
3122921369369498K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMID1996-05-23
65951804633438K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMID1996-05-23
3122921351158357K955134ORGENTEC ENASCREEN ELISA ASSAYLLL1996-03-20
65951973132134K955134ORGENTEC ENASCREEN ELISA ASSAYLLL1996-03-20
3122921858942604K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYLRM1995-11-09
65952061173793K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYLRM1995-11-09
65951256264181K952130ORGENTEC ANTI-TG ELISAJZO1995-06-20
3122921368573646K952130ORGENTEC ANTI-TG ELISAJZO1995-06-20
65951483127527K952129ORGENTEC ANTI-TPO ELISAJZO1995-06-20
3122921928808001K952129ORGENTEC ANTI-TPO ELISAJZO1995-06-20
65951698823375K951363CARDIOLIPIN IGG,M,A EIA TEST SYSTEMMID1995-10-13
65951829671586K951329IMMUCHEM GAL-MW EAJIA1995-11-09
65951047142219K944449EBV-VCA IGM ELISA TEST STSTEMLSE1995-09-25
3122921482245827K944449EBV-VCA IGM ELISA TEST STSTEMLSE1995-09-25
3122921187966512K941409ENA PROFILE-6 ELISA TEST SYSTEMLJM1994-06-10
65951520166313K941409ENA PROFILE-6 ELISA TEST SYSTEMLJM1994-06-10
65951208609851K941014ENA SCREEN ELISA TEST SYSTEMLJM1994-06-10
3122921821202624K941014ENA SCREEN ELISA TEST SYSTEMLJM1994-06-10
3122921147644725K940362ANA SCREEN ELISA TEST SYSTEMLLL1994-07-28
65951460129172K940362ANA SCREEN ELISA TEST SYSTEMLLL1994-07-28
65951688359655K936010THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAYDDC1994-07-18
65951629325217K933267AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEMLJM1993-12-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJM202003-05-02
MID131998-06-02
MOB92004-04-05
CDZ82018-07-20
JLW71999-06-22
KLI62003-08-22
DDC61999-06-25
LSR61990-05-02
JZO52003-09-10
DHR42010-10-27
NOP42004-11-19
CDP41999-06-02
MST41999-03-26
LSE41998-08-21
LLL41996-03-20
MRG32013-07-15
JJX32011-09-06
CGJ32005-11-30
LFZ31993-04-02
QCU22018-08-27
LDJ22013-10-18
PCG22012-12-20
JLX22008-01-29
JLS22004-07-22
DJR22002-11-22
DJG22002-05-06
CEC22002-04-05
DCK22001-07-20
DKZ22001-04-20
JZG22000-09-26
GGT22000-06-07
DGC21999-09-21
LYR21999-08-12
JHI21999-07-22
JKR21998-09-03
CKG21998-08-19
LCX21998-03-11
CEW21997-12-23
LJZ21997-08-20
JNL21997-07-03

GUDID#

ANA Screen IgG ELISA - The ANA Screen ELISA test system is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to the enclosed instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns.

DRG International Inc

2023-08-23

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