FDA.reportPublic FDA data

ALFA WASSERMANN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22472881000122044ALFA WASSERMANN1Y2026-01-014 Henderson Dr West Caldwell NJ US 07006

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
00857969006068ACE - Creatinine Reagent973-852-0158HKatz@AlfaWassermannUS.com
00857969006112ACE - Creatinine Reagent973-852-0158HKatz@AlfaWassermannUS.com
00857969006136ACE - Albumin Reagent973-852-0158HKatz@AlfaWassermannUS.com
00857969006396Alfa Wassermann - Level 1 Chemistry Control(973) 852-0158HKatz@AlfaWassermannUS.com
00857969006402Alfa Wassermann - Level 2 Chemistry Control(973) 852-0158HKatz@AlfaWassermannUS.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
983651396858279K993853K-ASSAY MULTI-ANALYTE CALIBRATORJIX1999-12-27
983651700140975K993606K-ASSAY APO A1/B CALIBRATOR SETJIX1999-11-26
983651967976347K993537K-ASSAY TRANSFERRINDDG1999-11-30
983651063989315K993354K-ASSAY APO BDER1999-10-28
983651857465329K993345K-ASSAY APO AIDER1999-10-25
983651530481456K992766N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETMRR1999-10-18
983651600109072K991733ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSMRR1999-07-13
983651998964151K991166K-ASSAY MICROALBUMIN CALIBRATOR SETJIX1999-06-10
983651435880124K983130LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSJJY1998-09-29
983651334228007K981609BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30CIG1998-06-03
983652069594245K981377ACE T4 REAGENT T4 CALIBRATORSKLI1998-06-10
983652028480439K974874BILIRUBIN-SL (TOTAL) ASSAYCIG1998-02-12
983651553084398K974003ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30CKA1997-12-05
983652003306659K973999CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30CGS1998-03-11
983651649854200K973588LIQUID ALKALINE PHOSHATASE REAGENT SETCJE1997-10-22
983651740569960K961588TOTAL IRON (NITRO-PAPS) REAGENT SETJIY1996-11-18
983651017628015K961281TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60CDT1996-08-16
983651946519915K955496URIC ACID CATALOGE# 220-93/94/97KNK1996-02-23
983651533585505K952426MAGNESIUM REAGENTJGJ1995-08-07
983651307018209K941132LIQUID AST (SGOT)REAGENT SETCIT1994-05-02
983651115851590K940735LIQUID AMYLASE (CNPG3) REAGENT SETCIJ1994-08-01
983651425609251K933862ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)JGS1993-10-12
983651960221883K931786ACE CLINICAL CHEMISTRY SYSTEMJJE1993-09-21
983651350337664K930104ACE CLINICAL CHEMISTRY SYSTEMJIX1993-08-23
983651778660000K923091KING DIAGNOSTICS GAMMA GT REAGENTJPZ1992-09-09
983651393402557K922969KING DIAGNOSTICS UREA NITROGEN REAGENTCDN1992-10-13
983651274475515K895873CALCIUM, CATALOGUE NUMBER140-20CJY1989-12-12
983651340612847K844344GEMCAL ENI REFERENCE SERUMJIX1985-01-03
983651188238653K843104ALBUMIN ASSAY KITCIX1984-09-07
983651564255495K842160CHOLESTEROL ASSSAY KITCHH1984-08-17
983651786944479K832744STARLYTEJGS1983-11-03
983651240476038K822470PSI INORGANIC PHOSPHORUSCEO1982-09-14
983651997683262K822468PSI TOTAL PROTEIN REAGENTCEK1982-09-14
983651244367628K170623ACE Hemoglobin A1c (HbA1c) ReagentLCP2018-02-27
983651332326032K132156RANDOX CSF CONTROLS LEVELS 2 AND 3JJY2013-10-23
983651940183751K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTCFJ2013-10-02
983651208136245K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTKLI2013-08-14
983651491155500K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTCIX2013-08-19
983651199967175K131351ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENTCJE2013-08-15
983651870788724K130337RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3JJY2013-06-19
983651178871889K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTKHS2013-05-02
983651388654460K123322ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENTCDN2013-05-21
983651782367709K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULECFR2013-04-23
983651319082072K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTCHH2012-10-05
983651497517314K122302ACE MAGNESIUM REGENTJGJ2012-08-27
983651232177601K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTJMO2012-06-01
983651614508476K113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENTLCP2012-08-06
983651831444479K113436ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENTCJE2012-07-12
983651012598667K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTKHS2012-07-02
983652047911294K113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTCDN2012-08-10
983651739430600K113382ACE ALT REAGENTCKA2012-07-19
983651848823788K113374ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENTCIX2012-07-13
983651477748355K113262ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTCHH2012-07-03
983651314845050K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTJJE2012-05-17
983651004790286K112538ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTCHH2012-03-29
983651314553563K103615ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDCDN2011-09-08
983651503140151K063306ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72LCP2007-04-17
983651247090959K053153RANDOX CALIBRATION SERUMJIX2006-01-13
983651239052037K023853K-ASSAY LP(A) CONTROLSDFC2002-12-13
983651517291722K023739GLUCOSE-SL-C ASSAY, MODEL 257-30CFR2003-01-17
983651566109374K021897RANDOX HAEMOGLOBIN A1CLCP2002-11-26
983651155470478K021660K-ASSAY LP(A) ASSAYDFC2002-07-25
983652009925844K012855LIQUISPX LIQUID LIPID CONTROLJJY2001-08-30
983651623000084K002354CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80KHS2000-09-26
983651107206818K000055CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17CGX2000-02-18
983651067615875
983651124222901
983651252869261
983651284549828
983651371462623
983651372610805
983651562936158

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIX62006-01-13
LCP42018-02-27
JJY42013-10-23
CDN42013-05-21
CHH42012-10-05
CIX32013-08-19
CJE32013-08-15
KHS32013-05-02
KLI22013-08-14
CFR22013-04-23
JGJ22012-08-27
CKA22012-07-19
JJE22012-05-17
DFC22002-12-13
DER21999-10-28
MRR21999-10-18
CIG21998-06-03
JGS21993-10-12
CFJ12013-10-02
JMO12012-06-01
CGX12000-02-18
DDG11999-11-30
CGS11998-03-11
JIY11996-11-18
CDT11996-08-16
KNK11996-02-23
CIJ11994-08-01
CIT11994-05-02
JPZ11992-09-09
CJY11989-12-12
CEK11982-09-14
CEO11982-09-14

PMN#

S-TEST C02

2008-06-26

ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.

S-TEST CA

2008-06-24

ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.

GUDID#

71 records. Showing 1-40. Next