FDA.reportPublic FDA data

Chemco

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10584581000158594CHEMLINK LABORATORIES, LLC.1N2026-01-013960 ROYAL DRIVE SUITE 500 Kennesaw GA US 30144
10671683002638508CHEMENCE MEDICAL INC.1N2026-01-01185 BLUEGRASS VALLEY PARKWAY Alpharetta GA US 30005
16136161613616CHEMICAL SERVICE LABS, LLC1N2026-01-0117817 Davenport Rd # 135 DALLAS TX US 75252
18253961825396CHEMATICS, INC.1N2026-01-01HWY. 13 SOUTH NORTH WEBSTER IN US 46555
24319802431980CHEMBIO DIAGNOSTIC SYSTEMS, INC.1N2026-01-013661 HORSEBLOCK RD. MEDFORD NY US 11763
96161393003287780CHEMIGLAS CORP.1N2026-01-01311, Chungnyeol-ro Yangsan Gyeongnam KR 626-230
10005704451000570445CHEMISCHE FABRIK DR. WEIGERT GMBH & CO. KG1N2026-01-01Muehlenhagen 85 Hamburg DE 20539
30022911073002291107CHEMCLEAN CORPORATION1N2026-01-01130-45 180th Street Jamaica NY US 11434
30048837543004883754CHEMIGRAPHIC LTD1N2026-01-01Unit A2 Fleming Centre, Fleming Way Crawley West Sussex GB RH109NF
30068992713006899271Chemilens.Co., Ltd.1N2026-01-0189, Jiaxing EDZ, ChangSheng East RD Jiaxing City Zhejiang CN 314003
30088523063008852306Chemtron Biotech, Inc.1N2026-01-019245 Brown Deer Rd Ste B San Diego CA US 92121
30100347603010034760CHEMENCE MEDICAL INC.1N2026-01-01200 Technology Dr Alpharetta GA US 30005
30151776523015177652ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece1N2026-01-013411 Silverside Rd Ste 248 Wilmington DE US 19810
30265658543026565854Chembio Diagnostic Systems1N2026-01-011560 Fifth Avenue Bay Shore NY US 11706
10584581000158594CHEMLINK LABORATORIES, LLC.1N2020-04-253960 ROYAL DRIVE SUITE 500 Kennesaw GA US 30144
10003269881000326988CHEMETRICS, INC.1N2020-04-254295 Catlett Rd Midland VA US 22728
30154175773015417577CHEMBIO DIAGNOSTIC SYSTEMS, INC.1N2020-04-25555 Wireless Blvd -- Hauppauge NY US 11788

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
372591631896261K981913PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAYLSR1999-02-12
39601369497939K943503CHEMCARD GLUCOSE TESTCGA1996-07-23
39601880945024K864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODCHH1988-06-10
372591047589688K841272SICKLE-STAT HEMOGLOBIN S SCREEN KITGHM1984-04-13
2243451481888664K232917Chemo MouthpieceQUA2024-01-23
1263721373421422K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestDJG2023-12-20
1502662044613322K212246Exofin Precision PenMPN2021-09-09
372591223729752K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK2022-11-04
3140321223729752K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK2022-11-04
372591775969049K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderQFO2020-06-03
3140321775969049K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderQFO2020-06-03
1502661572751588K200264Exofin High Viscosity Topical Skin AdhesiveMPN2020-12-17
1502661461442259K191461Exofin Fusion Skin Closure SystemOMD2020-06-05
1263721983917363K181305OralTox Oral fluid Drug TestDJC2018-09-20
1502662045927066K171442Exofin Fusion Skin Closure SystemOMD2017-09-25
1502661011278324K162352derma+flex QS High Viscosity Tissue AdhesiveMPN2016-12-22
1263721486292301K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsDJG2016-04-18
1502661266219390K152476Exofin High Viscosity Tissue AdhesiveMPN2016-02-09
1263721771598691K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJG2015-04-17
1263722028594283K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJG2014-10-09
1263721370920736K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTLCX2013-07-26
1263721961113659K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTJHI2013-05-30
1263721795353578K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSJXM2012-11-29
1263721365697016K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSDKZ2012-05-17
39601393629811K121256ALCO-SCREEN 02DIC2012-09-12
39602058922564K121247ALCO-SCREENDIC2013-03-22
1263721758690804K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDJXM2011-09-14
1502662058608576K101276DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404MPN2010-07-28
1502661985459773K0534093M LIQUID BANDAGEKMF2006-06-19
1502661636569337K050757FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGEKMF2006-02-23
1511711241158816K020612SULTAN SPOROX TEST VIAL, MODEL 75195JOJ2002-05-07
372591520495084DEN220023Procise ADLQYD2023-09-29
3140321520495084DEN220023Procise ADLQYD2023-09-29
372591874491930DEN210056Procise IFXQXT2023-09-29
3140321874491930DEN210056Procise IFXQXT2023-09-29
372591612122346BP180191
3140321612122346BP180191
372592071783988BP120032
2282482071783988BP120032
3140322071783988BP120032
372591644858497BP050010
2282481644858497BP050010
3140321644858497BP050010
372591935880440BP050009
2282481935880440BP050009
3140321935880440BP050009
764371051018121
764371280487160
372591355693512
372591367097767
372591412910397
372591599258548
764371756456025
1263721909434325
3450721010169745
2243451082358744
1502661126438666
372591164800073
3140321164800073
3450721168835343
372591196863456
3140321196863456
3450721199792095
372591203501902
3140321203501902
2243451215698743
2243451229642638
1263721290184531
321211309669275
2243451324616246
2052251335505148
792881340806192
2243451352827899
3140321355693512
372591417634285
3140321417634285
39601424811024
372591430810002
3140321430810002
372591453912107
3140321453912107
1263721496808504
3453911499646814
321211500564859
1502661539441394
372591556428107
3140321556428107
2243451569402191
372591595865827
3140321595865827
3140321599258548
2243451619502932
2109641665050871
1263721686792203
1263721723806621
1263721757992916
792931802094618
372591809922621
3140321809922621
3453911834771960
321211840886886
2243451847301886
727451893777209
1502661893777209
1263721913696684
1263721924157711
1502661943569577
1502661948353411
727451985459773
1263722022278144
2052252030647202
321212052475322
2243452056072874
1263722060401838

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MPN52021-09-09
DJG42023-12-20
KMF32006-06-19
QYD22023-09-29
QXT22023-09-29
DCK22022-11-04
OMD22020-06-05
QFO22020-06-03
DIC22013-03-22
JXM22012-11-29
QUA12024-01-23
DJC12018-09-20
LCX12013-07-26
JHI12013-05-30
DKZ12012-05-17
JOJ12002-05-07
LSR11999-02-12
CGA11996-07-23
CHH11988-06-10
GHM11984-04-13

NDC#

PMN#

79 records. Showing 1-40. Next

Applications#

GUDID#

ProciseDx Calibration Cartridge - The ProciseDx Calibration Cartridge is an accessory with quantitative assigned values to the ProciseDx Analyzer and is used to confirm that the instrument is operating within specified limits. The calibration cartridge does not contact biological specimens and is not used for diagnostic testing. The intended users are clinical laboratory professionals responsible for completing a periodic calibration check of the ProciseDx Analyzer.

Chembio Diagnostic Systems Inc.

2024-08-06

Procise ADL - The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.

Chembio Diagnostic Systems Inc.

2024-08-16

Procise IFX - The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer.Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.

Chembio Diagnostic Systems Inc.

2024-08-16

80 records. Showing 1-40. Next