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Fisher Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11811211181121Fisher Diagnostics1Y2026-01-018365 VALLEY PIKE MIDDLETOWN VA US 22645

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
00845275000504Thermo Scientific Pacific Hemostasis® - 100301800-528-0494xx@xx.xx
00845275000559Thermo Scientific Pacific Hemostasis® - 100595800-528-0494xx@xx.xx
00845275000566Thermo Scientific Pacific Hemostasis® - 100596800-528-0494xx@xx.xx
00845275000573Thermo Scientific Pacific Hemostasis® - 100597800-528-0494xx@xx.xx
00845275000580Thermo Scientific Pacific Hemostasis® - 100601800-528-0494xx@xx.xx
00845275000634Thermo Scientific Pacific Hemostasis® - 100308800-528-0494xx@xx.xx
00845275000658Thermo Scientific Pacific Hemostasis® - 100312800-528-0494xx@xxx.xx
00845275000818Thermo Scientific Pacific Hemostasis® - 100560800-528-0494xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
76471805004940K994100PACIFIC HEMOSTASIS THROMBOPLASTIN DGJS2000-02-18
76471194186863K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CKQG1999-09-03
76471372636082K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200KQG1999-06-21
76471418176867K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMAGJT1999-02-17
76471486772304K984131COAGULATION CONTROL LEVEL 3 (ABNORMAL)GGC1998-12-01
76471176754134K984130COAGULATION CONTROL LEVEL 2 (ABNORMAL)GGC1998-12-01
76471100459279K984129COAGULATION CONTROL LEVEL 1 (NORMAL)GIZ1998-12-01
76471646511956K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
76471392952281K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
76471031120009K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)CFR1998-03-10
76471673699939K974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)JIF1998-01-02
76471715970114K974290MICROPROTEIN STANDARD KITJIX1997-12-19
76471053808780K973869TRACE REAGENT LINE FOR THE COBAS MIRACKA1998-01-07
76471082307667K972333AMMONIA/IRON STANDARD KITJIX1997-07-23
76471555658958K971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)CDO1997-05-27
76472057003813K971477UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)CDQ1997-05-27
76471669305904K962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)CHH1996-09-27
76471168385232K961984PORPHOBILINOGEN (PBG)JNF1996-12-10
76471064700802K961477TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGYCDT1996-08-05
76471521415804K961123ALT INCORPORATING DSTCKA1996-04-25
76471209328759K961114AST INCORPORATING DSTCIT1996-05-23
76471536364697K955300TOTAL BILIRUBIN PROCEDURECIG1995-12-20
76471510294819K954074AALTO SCIENTIFIC LIQUID CARDIAC CONTROLJJY1995-10-07
76471445458428K953971TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGYCDT1996-04-05
76471182189516K944462DMA IRON PROCEDUREJIY1994-11-15
76471328401807K942424DMA MICROPROTEIN PROCEDURECEK1994-09-06
76472063876660K940082THROMBOSCREEN THROMBOPLASTIN-DSGJS1995-02-14
76471052385938K931786ACE CLINICAL CHEMISTRY SYSTEMJJE1993-09-21
76471987219993K931559DMA AMYLASE PROCEDURECIW1993-10-28
76471665157171K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJIS1993-06-07
76471030996066K925906NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLJJX1993-02-18
76471069916138K925794TRACE MICROPROTEIN REAGENTJGQ1993-03-29
76471586953637K922995LIPID CONTROLSJJX1992-08-12
76471199463535K920668MINUTEX D-DIMER LATEX TESTGHH1992-10-16
76471110018611K920603TRACE MAGNESIUM - ARSENAZO REAGENTJGJ1992-03-11
76471159843723K915803DMA LD KINETIC PROCEDURECFJ1992-03-18
76471613154862K914731TRACE GAMMA GT-SS REAGENTJQB1991-11-19
76471506427865K913371TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CALJIT1991-11-08
76471813469762K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDJIN1991-03-04
76471784045920K904989CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-IIJJY1991-01-23
76471918735361K903896CALCIUM ARSENAZO III REAGENTCIC1990-09-13
76471555457157K891761GDS ENZYMATIC THEOPHYLLINE REAGENTLCY1989-05-16
76471600628901K891337THROMBOSCREEN APTT REAGENTGFO1989-04-21
76471597846361K882116TOTAL PROTEIN/ALBUMIN STANDARDJIX1988-06-24
76471360999025K880798ACID PHOSPHATASE REAGENTCKB1988-04-18
76471307616817K880795RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.CJE1988-04-18
76472043313275K875285MULTI-CHEMISTRY LINEARITY STANDARDJIX1988-09-02
76471477093907K872023AMYLASE TEST KITJFJ1987-08-05
76471803744280K870372ALBUMIN REAGENT - BROMCRESOL GREEN METHODCIX1987-08-19
76471083122029K870371TOTAL PROTEIN REAGENT - BIURET METHODCEK1987-08-19
76471058182736K870368PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTIONCEO1987-08-19
76471208635340K870362CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHODCIC1987-08-21
76471624538820K863586GAMMA GLUTAMYL TRANSFERASE PROCEDUREJPZ1986-10-03
76471007320515K863585CHLORIDE PROCEDURECHJ1986-10-16
76471055126891K863264INORGANIC PHOSPHORUS PROCEDURECEO1986-09-11
76471969011732K861667ALKALINE PHOSPHATASE PROCEDURECJE1986-05-29
76471622438986K861665CREATINE PHROSPHOKINASE (CK) PROCEDURECGS1986-06-05
76471240225268K861658ALT/GPT PROCEDURECKA1986-05-29
76471575665455K861655CREATININE PROCEDURECGX1986-07-01
76471911257213K861654ALBUMIN PROCEDURECIX1986-06-13
76471171212579K860728L D H-L (LACTIC DEHYDROGENASE) REAGENTCFJ1986-04-07
76471249656171K860726ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXIDLFR1986-04-21
76471432758757K860715ALP (ALKALINE PHOSPHATASE) REAGENTCJE1986-04-24
76471440896022K854079THROMBO SCREEN SICKLE CELL ASSAY SETGHM1985-10-31
76471445575981K852512THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KITGHH1985-09-17
76471509038955K834086CONTACT-K APTT REAGENTGGN1984-02-03
76471264510259K831844DIRECT BILIRUBIN REAGENTCIG1983-07-18
76471303697510K812110GILCHEM CALCIUM REAGENTCIC1981-08-13
76471063196166K800826FIBRINOGEN SCREENKQJ1980-05-30
76471580969050K791725CHOLINESTERASE REAGENTDIH1979-10-17
76471877065497K781880ASSAY KIT, THROMBO-SCREENGIS1978-12-04
76471260382235K781865IRON BINDING CAPICITY MODEL 0370JIY1978-12-04
76471703117393K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsPRI2017-06-01
76471920742776K070064AMYLASE EPS REAGENTJFJ2007-05-22
76471205382873K062204ARCHITECT CORTISOL ASSAYJFT2006-09-22
76471791450583K061412THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401JFY2007-03-23
76471381015561K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSJZO2006-07-18
76471722597808K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMJZO2006-05-10
76471696440550K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETJIT2005-11-09
76471285748504K052056DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUMJJY2005-09-23
76471628933932K042924ARCHITECT STAT MYO IMMUNOASSAYDDR2005-01-24
76471786300741K042307ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)JIT2004-11-03
76471954869306K041657THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENTKQN2004-08-30
76471472173086K041596ARCHITECT STAT CK-MB IMMUNOASSAYJHX2004-07-21
76471521261842K041192ARCHITECT STAT TROPONIN-I IMMUNOASSAYMMI2004-08-12
76472040602872K033674MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLSLCP2004-02-09
76471175369878K032753GLUCOSE TOLERANCE BEVERAGEMRV2003-11-18
76471420056509K023362FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLINGKP2002-12-09
76471120148079K022108THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050JIX2002-07-25
76471228876698K013995MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TLJJY2001-12-21
76471863776135K013397PACIFIC HEMOSTASIS REFERENCE EMULSIONJIX2002-02-15
76471319231229K012878THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609JIS2001-10-16
76471521165037K010750PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560GGN2001-09-07
76471315219295K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901NDW2001-01-17
76472010188678K002642MINIQUANT D-DIMER, MODEL 1447DAP2001-02-05
76471116413344K000781DIRECT TIBC KITJMO2000-05-02
76471497832284K000679THROMBOSTRATE CONTROL PLASMASGGN2000-03-24
76471021089040
76471033696162
76471133558824
76471294068719
76471323612530
76471335654499
76471342126415
76471374597962
76471523312354
76471531232470
76471581342453
76471601796478
76471678008593
76471695924024
76471726488554
76471775207392
76471780282072
76471781484588
76471796108320
76471830748891
76471839812131
76471840357967

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIX62002-07-25
JJY42005-09-23
JIT32005-11-09
GGN32001-09-07
CKA31998-01-07
CEK31994-09-06
CIC31990-09-13
CJE31988-04-18
JFJ22007-05-22
JZO22006-07-18
JIS22001-10-16
GJS22000-02-18
KQG21999-09-03
GGC21998-12-01
CDT21996-08-05
CIG21995-12-20
JIY21994-11-15
JJX21993-02-18
GHH21992-10-16
CFJ21992-03-18
CIX21987-08-19
CEO21987-08-19
PRI12017-06-01
JFY12007-03-23
JFT12006-09-22
DDR12005-01-24
KQN12004-08-30
MMI12004-08-12
JHX12004-07-21
LCP12004-02-09
MRV12003-11-18
GKP12002-12-09
DAP12001-02-05
NDW12001-01-17
JMO12000-05-02
GJT11999-02-17
GIZ11998-12-01
MRR11998-09-11
LBS11998-07-30
CFR11998-03-10

PMN#

GUDID#

122 records. Showing 1-40. Next