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 |