FDA.reportPublic FDA data

HELENA LABORATORIES, CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16189821618982HELENA LABORATORIES, CORP.1Y2026-01-011530 Lindbergh Dr BEAUMONT TX US 77707
16444741000116989HELENA LABORATORIES, CORP.1Y2026-01-013795 WASHINGTON BLVD. BEAUMONT TX US 77705

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
31181601814219K992199ACID HEMOGLOBIN KITJBD1999-09-21
31181427228610K983914REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KITGGP1998-12-22
31181041068222K983649MAX-ACTJBP1998-12-11
31181884518426K982426SPIFE ALKALINE HEMOGLOBINJBD1998-12-17
31181905992978K973040SPIFE IFE-6CFF1998-01-02
31181622335889K972482REAADS PROTEIN S ANTIGEN TEST KITGGP1997-08-13
31181011161076K972342REAADS PROTEIN C ANTIGEN TEST KITGGP1997-10-06
31181585897601K972274SPIFECEF1997-10-27
31191585897601K972274SPIFECEF1997-10-27
31181399535411K972005REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KITGGP1997-08-13
31181628909798K964609ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBEJBP1997-03-06
31181964180414K950590REP CHOLESTEROL PROFILE CONTROLJJX1995-03-30
31181172332843K941860SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)GGN1994-09-14
31181968423959K941737SPECIALTY ASSAYED CONTROL-1GIZ1994-10-07
31191504888888K931956CASCADE M, CAT. NO. 1710GKP1993-08-23
31181256384135K931247TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067DAH1993-04-27
31181755149900K926222OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376JPA1993-02-12
31181782893996K924915SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479JJY1992-12-18
31181543954877K921578TITAN GEL ALKALINE PHOSPHATASE (HR)CIN1992-09-23
31181361771932K920927KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024JJY1992-06-19
31181092366008K920926KEMTROL SERUM CONTROL-ABNORMALJJY1992-05-07
31182016452170K920147THROMBIN CLOTTING TIME REAGENTGJA1992-05-01
31182028748232K915418ELLAGIC ACID APTT REAGENTGFO1992-02-14
31181933812802K912774ARACHIDONIC ACIDJBX1991-08-22
31181811090856K911075COLOSCREENKHE1991-07-03
31182060450817K910800ADP REAGENTGHR1991-05-20
31181668950122K910706COLLAGEN REAGENT CAT. NO. 5368GHR1991-05-20
31182009175562K910680EPINEPHRINE REAGENT, CAT. NO. 5367GHR1991-05-20
31181723079562K905673AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183GGN1991-02-11
31181393165922K905149TITAN GELDAH1991-01-03
31181258337833K904247FREE PROTEIN S REAGENT CAT. NO. 5363GGP1991-01-18
31181837140222K897136PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357GGP1990-02-05
31181319687352K896174PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359GGP1990-03-15
31181556403518K895528GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104JJX1989-10-25
31181554124160K893038PROTOFLUOR ZJKJ1989-11-17
31191554124160K893038PROTOFLUOR ZJKJ1989-11-17
31181407655469K891683TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISERCZN1989-04-12
31181710337611K891188TITAN GEL IFE TRIVALENT ANTISERUMCFQ1989-03-22
31181554919779K882799HELENA COLOCAREKHE1988-09-30
31181578861740K872834TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410CZJ1987-08-12
31181378713767K871498TITAN GEL IMMUNOFIX CONTROLSDFT1987-04-29
31181952513363K870890ALKALINE PHOSPHATASE INDOLYL BLUE REAGENTCIN1987-06-01
31181437943404K841020FIBRINOGEN ASSAY KITKQJ1984-05-02
31181595035061K840329RISTOCETIN COFACTOR ASSAYGGP1984-04-05
31181644115881K834031FACTOR II DEFICIENT SUBSTRATE PLASMAGGP1983-12-16
31181462501562K833639TITANGEL HIGH RESOLUTION CONTROLJJY1984-01-04
31181972560005K832428PLATELET AGGREGATION REAGENT SETGHR1983-10-20
31181059690942K831603TITAN GE/IEPLATEJZR1983-07-07
31181192478920K823267FACTOR VIII RELATED ANTIGEN ROCKET EIDGGP1982-12-28
31181302396422K821982TITAN GEL SERUM CONTROLJJY1982-08-16
31181740687192K821981TITAN GEL CPK/LDH ISOENZYME CONTROLJJT1982-07-22
31181522623455K802232AB-TROL COAGULATION CONTROLGGW1980-11-12
31181210180126K800856A,FDA2 LYOPHILIZED HEMO CONTROLJBD1980-04-29
31181294247980K800855A,FSC LYOPHILIZED HEMO CONTROLJBD1980-04-29
31181924793535K800854A,A2 LYOPHILIZED HEMO CONTROLJBD1980-04-29
31181837206611K800853A,SA2 LYOPHILIZED HEMO CONTROLJBD1980-04-29
31181575537445K800432HELENA RISTOCETINJOZ1980-03-25
31181249369951K792656HELENA FACTOR XII DEFICIENTGGP1980-01-24
31181563993617K792511HELENA FACTOR VII DEFICIENT SUB. PLASMAGGP1979-12-31
31181340935524K792508HELENA FACTOR X DEFICIENT SUBSTRATEGGP1979-12-31
31181629055048K792507HELENA FACTOR V DEFICIENT SUBSTRATEGGP1979-12-31
31181671056878K792476HELENA FACTOR XI DEFICIENT SUBSTRATEGGP1979-12-31
31181221949428K792475HELENA FACTOR IX DEFICIENT SUBSTRATEGGP1979-12-31
31182010570302K792335HELENA FACTOR VIII DEFICIENT SUB. PLASMAGGP1979-12-04
31182000417869K792310NORM-TROLJPA1979-12-04
31181487916716K792024LIPOTROLJJY1979-10-30
31181854756133K213396SPIFE A1AT kitOBZ2022-10-13
31181654670894K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA2022-04-19
31181296333786K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLJJY2013-10-07
31181839263996K100103SPECIALTY ASSAYED CONTROL-2GGC2010-12-15
31181927331354K070660INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TESTKHE2007-06-21
31182047538327K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAGHR2007-02-23
31181952018853K061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458CFF2006-07-06
31181038174635K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPJPA2006-05-10
31191784261372K050053HEMORAM/AGGRAM ANALYZERJPA2005-07-11
31181096345329K040296PHOSPHOPLASTIN RLGJS2004-05-24
31181461204956K024162SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389CFF2003-02-19
31181631113999K023761PLATELETWORKS, MODELS PW-A, PW-CJOZ2003-02-14
31182031416806K022757SPIFE CK KIT, MODEL 3332, 3333JHY2002-10-11
31191694799203K020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770JBP2002-05-23
31182027331123K020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346CIN2002-05-06
31181726559757K020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452CFE2002-03-29
31181779105338K013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343JHO2001-12-21
31191828587258K013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752JBP2002-01-10
31181260093206K003359COLOSCREEN-ESKHE2000-11-27
31181894181439K000603SPIFE CHOLESTEROL PROFILE KITJHO2000-04-17
31181000675826
31181047227601
31181051076076
31181053907013
31181054018160
31181055043557
31181081146138
31191084205761
31181084205761
31191094613846
31181105410268
31181111659875
31181193128930
31181209176788
31181221832841
31181319190749
31181337177214
31181339567248
31181343251708
31181343476366
31191362168740
31181382039584
31191390392082
31181390392082
31181465610482
31181467110352
31191472273677
31181552066762
31181557938463
31181586039372
31181601732980
31181603775119
31181636495693
31181688130761

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GGP171998-12-22
JJY72013-10-07
JBD61999-09-21
GHR52007-02-23
KHE42007-06-21
JPA42006-05-10
JBP42002-05-23
CFF32006-07-06
CIN32002-05-06
JOZ22003-02-14
JHO22001-12-21
CEF21997-10-27
JJX21995-03-30
GGN21994-09-14
DAH21993-04-27
JKJ21989-11-17
OBZ12022-10-13
GKA12022-04-19
GGC12010-12-15
GJS12004-05-24
JHY12002-10-11
CFE12002-03-29
GIZ11994-10-07
GKP11993-08-23
GJA11992-05-01
GFO11992-02-14
JBX11991-08-22
CZN11989-04-12
CFQ11989-03-22
CZJ11987-08-12
DFT11987-04-29
KQJ11984-05-02
JZR11983-07-07
JJT11982-07-22
GGW11980-11-12

PMN#