FDA.reportPublic FDA data

LABORATORIOS SCANTIBODIES S.A. DE C.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30027922843002792284LABORATORIOS SCANTIBODIES S.A. DE C.V.1N2026-01-01Calle Los Vinedos #4100 Parque Industrial El Bajio CP 21430 TECATE Baja California MX --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
341071927205356K991747QUICKVUE ONE-STEP H. PYLORI II TESTLYR1999-08-04
341071486395900K991633QUICKVUE INFLUENZA A/B TESTPSZ1999-09-24
341071836051269K974108SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)JJX1997-11-26
341071061603372K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBOJHI1997-11-26
341071504794515K955108CARDS Q.S. STREP AGTZ1996-04-15
341071294642173K946276QUICKVUE(R) CHLAMYDIA TESTLJC1995-05-19
341071039716785K945080QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)GTY1995-02-10
341072029271541K934484QUICKVUE IN-LINE ONE-STEP STREP A TESTGTZ1994-07-18
341071794717386K931761QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)JJX1993-06-22
341071504043076K912868GROUP A STREP POSITIVE AND NEGATIVE CONTROLSGTZ1991-08-07
341071080072805K902510CARDS O.S. MONOKTN1990-07-16
341072020507432K141775SOFIA (R) STREP A+ FIAGTY2014-12-16
341071017049466K131166SOFIA(R) HCG FIAJHI2013-08-02
341071788289420K130398SOFIA(R) RSV FIAGQG2013-08-13
341072037892069K123793SOFIA STREP A FIAGTY2013-06-17
341071278515184K112177SOFIA ANALYZER AND INFLUENZA A+B FIAPSZ2011-10-24
341071458750825K102175RAPIDVUE HCG TESTJHI2010-08-25
341071535420223K101918QUICKVUE RSV 10GQG2010-09-24
341071377020125K070747QUICK VUE RSV TEST, MODELS 20193, 20199GQG2007-04-23
341071387158933K053146QUICKVUE INFLUENZA A + B TESTPSZ2005-12-14
341071300557151K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011CKG2005-05-20
341072024692193K030258FIRST RESPONSE PREGNANCY TESTLCX2003-02-25
341071899717320K021423INSTANT-VIEW FECAL OCCULT BLOOD RAPID TESTKHE2002-06-17
341071195517609K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100CKG2002-06-03
341071554610529K020801QUICKVUE ONE-STEP HCG-COMBOJHI2002-05-17
341071044948259K020799QUICKVUE ONE-STEP HCG-URINEJHI2002-05-17
341071038805476K011097QUICKVUE DIPSTICK STREP AGTY2001-05-08
341071017049466
341071038805476
341071039716785
341071044948259
341071061603372
341071080072805
341071196245486
341071223096295
341071278515184
341071294642173
341071297719973
341071377020125
341071387158933
341071458750825
341071486395900
341071504043076
341071504794515
341071534242677
341071535420223
341071554610529
341071574525547
341071581782265
341071601983223
341071788289420
341071794717386
341071800819047
341071832082106
341071836051269
341071899717320
341071927205356
341071967132643
341071991098113
341071991482472
341072020507432
341072024692193
341072029271541
341072037892069
341072068945051

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JHI52013-08-02
GTY42014-12-16
GQG32013-08-13
PSZ32011-10-24
GTZ31996-04-15
CKG22005-05-20
JJX21997-11-26
LCX12003-02-25
KHE12002-06-17
LYR11999-08-04
LJC11995-05-19
KTN11990-07-16