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.
Registration Number | 3005432203 |
FEI Number | 3005432203 |
Name | GENCHEM, INC. |
Owner & Operator | GENCHEM, INC. |
Contact Address | 313 Gallimore Dairy Rd Suite 430 Greensboro NC 27409 US |
Official Correspondent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 510 W Central Ave Ste D BREA, CA 92821 US |
Establishment Type |
|
Device Company | Device | Date |
---|---|---|
GENCHEM, INC. | Sputolysin | 2019-10-28 |
GENCHEM, INC. | Aldolase Liquid Control | 2019-10-28 |
GENCHEM, INC. | Aldolase Controls | 2019-10-28 |
GENCHEM INC | GENCHEM™ Total Protein Reagent GEN-TP3 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Total Protein Reagent GEN-TP | 2018-07-06 |
GENCHEM INC | GENCHEM™ Total Bilirubin Reagent GEN-TBILI R3 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Total Bilirubin Reagent GEN-TBILI R2 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Total Bilirubin Reagent GEN-TBILI R1 | 2018-07-06 |
GENCHEM INC | GENCHEM™ ISE Electrolyte Reference GEN-ISE REFERENCE | 2018-07-06 |
GENCHEM INC | GENCHEM™ ISE Electrolyte Buffer GEN-ISE BUFFER | 2018-07-06 |
GENCHEM INC | GENCHEM™ Glucose Reagent GEN-GLU4 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Glucose Oxidase Reagent GEN-GLU LX | 2018-07-06 |
GENCHEM INC | GENCHEM™ Glucose Oxidase Reagent GEN-GLU3 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Direct Bilirubin Reagent GEN-DBILI R2 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Direct Bilirubin Reagent GEN-DBILI R1 | 2018-07-06 |
GENCHEM INC | GENCHEM™ CO2 Acid Reagent GEN-CO2ALK | 2018-07-06 |
GENCHEM INC | GENCHEM™ CO2 Acid Reagent GEN-CO2ACID | 2018-07-06 |
GENCHEM INC | GENCHEM™ CK-NAC Reagent GEN-CK R2 | 2018-07-06 |
GENCHEM INC | GENCHEM™ CK-NAC Reagent GEN-CK R1 | 2018-07-06 |
GENCHEM INC | GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3 GEN-CAL 3 | 2018-07-06 |
GENCHEM INC | GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2 GEN-CAL 2 | 2018-07-06 |
GENCHEM INC | GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1 GEN-CAL 1 | 2018-07-06 |
GENCHEM INC | GENCHEM™ UREA GEN-BUN R1 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN3 | 2018-07-06 |
GENCHEM INC | GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN LX | 2018-07-06 |
GENCHEM INC | GENCHEM™ Amylase Reagent GEN-AMY | 2018-07-06 |
GENCHEM INC | GENCHEM™ Alkaline Phosphatase GEN-ALP R2 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Alkaline Phosphatase GEN-ALP R1 | 2018-07-06 |
GENCHEM INC | GENCHEM™ Albumin Reagent GEN-ALB-G | 2018-07-06 |
GENCHEM INC | GENCHEM™ Albumin Reagent GEN-ALB | 2018-07-06 |
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-CA3 | 2018-03-29 |
GENCHEM INC | GENCHEM™ AST/SGOT GEN-AST R1 | 2018-03-29 |
GENCHEM, INC. | AST | 2015-07-09 |
GENCHEM, INC. | Synchron CX Multi-Analyte Calibrators | 2011-12-05 |
GENCHEM, INC. | Wash Concentrate | 2011-12-05 |
GENCHEM, INC. | GENCHEM CREATINE REAGENT | 2011-11-10 |
GENCHEM, INC. | GenChem, Inc., Calcium, Azo Dye Reagent | 2011-11-10 |
GENCHEM, INC. | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | 2009-06-05 |
GENCHEM, INC. | CK reagent | 2008-07-15 |
GENCHEM, INC. | Amylase Reagent | 2008-07-15 |
GENCHEM, INC. | Triglyceride | 2008-07-15 |
GENCHEM, INC. | Albumin BCP | 2008-07-15 |
GENCHEM, INC. | Direct Bilirubin Reagent | 2008-07-15 |
GENCHEM, INC. | Total Bilirubin | 2008-07-15 |
GENCHEM, INC. | BUN | 2006-08-31 |
GENCHEM, INC. | CHOLESTEROL | 2006-08-31 |
GENCHEM, INC. | GLUCOSE | 2006-08-31 |
GENCHEM, INC. | AST | 2006-08-31 |
GENCHEM, INC. | GENCHEM AST REAGENT 1 (BULK) | 2006-08-31 |
GENCHEM, INC. | ALKALINE PHOSPHATASE | 2006-08-31 |
GENCHEM, INC. | TOTAL PROTEIN | 2006-08-31 |
GENCHEM, INC. | ALBUMIN | 2006-08-31 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | CO2 REAGENT | 2005-11-22 |
GENCHEM, INC. | GLUCOSE OXIDASE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUN3 | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | ISE REFERENCE REAGENT | 2005-11-22 |
GENCHEM, INC. | BUFFER | 2005-11-22 |
GENCHEM, INC. | GENCHEM ELECTROLYTE BUFFER | 2004-12-27 |
GENCHEM, INC. | GENCHEM CREATININE REAGENT | 2004-12-27 |
GENCHEM, INC. | GENCHEM CO2 ACID REAGENT | 2004-12-27 |
GENCHEM, INC. | GLUCOSE OXIDASE, GLUCOSE | 2004-12-27 |
GENCHEM, INC. | BUN REAGENT | 2004-12-27 |
GENCHEM, INC. | CALCIUM, AZO DYE REAGENT | 2004-12-27 |
GENCHEM, INC. | GENCHEM ISE ELECTROLYTE REFERENCE | 2004-12-22 |