Genchem Inc

FDA Filings

This page includes the latest FDA filings for Genchem Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005432203
FEI Number3005432203
NameGENCHEM, INC.
Owner & OperatorGENCHEM, INC.
Contact Address313 Gallimore Dairy Rd Suite 430
Greensboro NC 27409 US
Official Correspondent
  • PATRICIA SHUGART
  • x-336-7228910-103
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address510 W Central Ave Ste D
BREA, CA 92821 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
GENCHEM, INC.
Sputolysin2019-10-28
GENCHEM, INC.
Aldolase Liquid Control2019-10-28
GENCHEM, INC.
Aldolase Controls2019-10-28
GENCHEM INC
GENCHEM™ Total Protein Reagent GEN-TP32018-07-06
GENCHEM INC
GENCHEM™ Total Protein Reagent GEN-TP2018-07-06
GENCHEM INC
GENCHEM™ Total Bilirubin Reagent GEN-TBILI R32018-07-06
GENCHEM INC
GENCHEM™ Total Bilirubin Reagent GEN-TBILI R22018-07-06
GENCHEM INC
GENCHEM™ Total Bilirubin Reagent GEN-TBILI R12018-07-06
GENCHEM INC
GENCHEM™ ISE Electrolyte Reference GEN-ISE REFERENCE2018-07-06
GENCHEM INC
GENCHEM™ ISE Electrolyte Buffer GEN-ISE BUFFER2018-07-06
GENCHEM INC
GENCHEM™ Glucose Reagent GEN-GLU42018-07-06
GENCHEM INC
GENCHEM™ Glucose Oxidase Reagent GEN-GLU LX2018-07-06
GENCHEM INC
GENCHEM™ Glucose Oxidase Reagent GEN-GLU32018-07-06
GENCHEM INC
GENCHEM™ Direct Bilirubin Reagent GEN-DBILI R22018-07-06
GENCHEM INC
GENCHEM™ Direct Bilirubin Reagent GEN-DBILI R12018-07-06
GENCHEM INC
GENCHEM™ CO2 Acid Reagent GEN-CO2ALK2018-07-06
GENCHEM INC
GENCHEM™ CO2 Acid Reagent GEN-CO2ACID2018-07-06
GENCHEM INC
GENCHEM™ CK-NAC Reagent GEN-CK R22018-07-06
GENCHEM INC
GENCHEM™ CK-NAC Reagent GEN-CK R12018-07-06
GENCHEM INC
GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3 GEN-CAL 32018-07-06
GENCHEM INC
GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2 GEN-CAL 22018-07-06
GENCHEM INC
GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1 GEN-CAL 12018-07-06
GENCHEM INC
GENCHEM™ UREA GEN-BUN R12018-07-06
GENCHEM INC
GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN32018-07-06
GENCHEM INC
GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN LX2018-07-06
GENCHEM INC
GENCHEM™ Amylase Reagent GEN-AMY2018-07-06
GENCHEM INC
GENCHEM™ Alkaline Phosphatase GEN-ALP R22018-07-06
GENCHEM INC
GENCHEM™ Alkaline Phosphatase GEN-ALP R12018-07-06
GENCHEM INC
GENCHEM™ Albumin Reagent GEN-ALB-G2018-07-06
GENCHEM INC
GENCHEM™ Albumin Reagent GEN-ALB2018-07-06
GENCHEM INC
GENCHEM™ Creatinine Test Reagent GEN-CREA R2(Acid)2018-03-29
GENCHEM INC
GENCHEM™ Creatinine Test Reagent GEN-CREA R1(Base)2018-03-29
GENCHEM INC
GENCHEM™Calcium, Azo Dye Reagent GEN-CA32018-03-29
GENCHEM INC
GENCHEM™ AST/SGOT GEN-AST R12018-03-29
GENCHEM, INC.
AST2015-07-09
GENCHEM, INC.
Synchron CX Multi-Analyte Calibrators2011-12-05
GENCHEM, INC.
Wash Concentrate2011-12-05
GENCHEM, INC.
GENCHEM CREATINE REAGENT2011-11-10
GENCHEM, INC.
GenChem, Inc., Calcium, Azo Dye Reagent2011-11-10
GENCHEM, INC.
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL32009-06-05
GENCHEM, INC.
CK reagent2008-07-15
GENCHEM, INC.
Amylase Reagent2008-07-15
GENCHEM, INC.
Triglyceride2008-07-15
GENCHEM, INC.
Albumin BCP2008-07-15
GENCHEM, INC.
Direct Bilirubin Reagent2008-07-15
GENCHEM, INC.
Total Bilirubin2008-07-15
GENCHEM, INC.
BUN2006-08-31
GENCHEM, INC.
CHOLESTEROL2006-08-31
GENCHEM, INC.
GLUCOSE2006-08-31
GENCHEM, INC.
AST2006-08-31
GENCHEM, INC.
GENCHEM AST REAGENT 1 (BULK)2006-08-31
GENCHEM, INC.
ALKALINE PHOSPHATASE2006-08-31
GENCHEM, INC.
TOTAL PROTEIN2006-08-31
GENCHEM, INC.
ALBUMIN2006-08-31
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
CO2 REAGENT2005-11-22
GENCHEM, INC.
GLUCOSE OXIDASE REAGENT2005-11-22
GENCHEM, INC.
BUN32005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
ISE REFERENCE REAGENT2005-11-22
GENCHEM, INC.
BUFFER2005-11-22
GENCHEM, INC.
GENCHEM ELECTROLYTE BUFFER2004-12-27
GENCHEM, INC.
GENCHEM CREATININE REAGENT2004-12-27
GENCHEM, INC.
GENCHEM CO2 ACID REAGENT2004-12-27
GENCHEM, INC.
GLUCOSE OXIDASE, GLUCOSE2004-12-27
GENCHEM, INC.
BUN REAGENT2004-12-27
GENCHEM, INC.
CALCIUM, AZO DYE REAGENT2004-12-27
GENCHEM, INC.
GENCHEM ISE ELECTROLYTE REFERENCE2004-12-22

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