This page includes the latest FDA filings for Pointe Scientific Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| POINTE SCIENTIFIC, INC. | Pointe Total Iron for the BS480 14-HI904-350 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Homocysteine for BS480 14-H7575-144 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe autoHDL for the BS480 14-H7545-400 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Glucose Hexokinase for BS480 14-G7517-480 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe GGT on BS480 14-G7571-200 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Carbon Dioxide on the BS480 14-C7502-160 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Cholesterol on BS480 14-C7510-480 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Calcium Arsenazo for BS480 14-C7529-360 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe AST on the BS480 Analyzer 14-A7561-375 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Amylase on BS480 Analyzer 14-A7564-120 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Alkaline Phosphatase on the BS480 14-A7516-225 | 2023-07-06 |
| POINTE SCIENTIFIC, INC. | Pointe Albumin on BS480 Analyzer 14-A7502-480 | 2022-06-10 |
| POINTE SCIENTIFIC, INC. | Pointe Scientific CK-MB C7563-90 | 2021-03-08 |
| POINTE SCIENTIFIC, INC. | Pointe Scientific CK-MB C7563-30 | 2021-03-08 |
| POINTE SCIENTIFIC, INC. | Pointe Uric Acid Reagent 16-HU982-308 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Triglyceride Reagent 16-T7532-520 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Total Protein Reagent 16-HT928-708 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe TIBC Reagent 16-I7517-400 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Total Bilirubin Reagent 16-HB979-395 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Phosphorus Reagent 16-HP916-192 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Magnesium Reagent 16-HM929-250 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lp(a) Reagent 16-L7597-160 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe autoLDL Cholesterol Reagent 16-L7574-400 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lactate Dehydrogenase Reagent 16-HL956-236 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lactic Acid Reagent 16-L7596-400 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Iron Reagent 16-HI904-398 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe autoHDL Cholesterol Reagent 16-H7545-320 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe HbA1c Reagent 16-H7546-200 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Glucose Reagent 16-G7517-528 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe GGT Reagent 16-HG959-236 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Direct Bilirubin Reagent 16-HB936-186 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe CRP Reagent 16-C7568-480 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Creatinine Reagent 16-C7539-487 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Carbon Dioxide Reagent 16-C7502-180 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Creatine Kinase Reagent 16-C7522-225 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Cholesterol Reagent 16-C7510-520 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Creatinine, Enzymatic Reagent 16-C7548-240 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Calcium Reagent 16-HC902-480 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe BUN Reagent 16-B7552-591 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe AST Reagent 16-A7561-420 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Amylase Reagent 16-HA965-223 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe ALT Reagent 16-A7526-420 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Alkaline Phosphatase Reagent 16-A7516-252 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Albumin Reagent 16-A7502-396 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Uric Acid Reagent 14-U7581-160 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Triglycerides Reagent 14-T7532-480 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Total Protein Reagent 14-T7528-480 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Direct TIBC Reagent 14-I7517-384 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Total Bilirubin Reagent 14-HB979-365 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Phosphorus Reagent 14-P7516-174 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Magnesium Reagent 14-HM929-240 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lp(a) Reagent 14-L7597-216 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe autoLDL Cholesterol Reagent 14-L7574-320 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lactate Dehydrogenase Reagent 14-L7572-200 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lactate Reagent 14-L7596-380 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe CRP Reagent 14-C7568-480 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe G6PD Controls G7583-CTL | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Lipoprotein (a) Control Set L7597-CTL | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe G6PD Reagent G7583-180 | 2021-02-08 |
| POINTE SCIENTIFIC, INC. | Pointe Hydrocodone 100 Reagent Set 60-HY0760-1L | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Hydrocodone 100 Reagent Set 60-HY0760-100 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Level 2 Control (MAMP 1250 ng/mL) 60-AM0096-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL) 60-AM0094-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL) 60-AM0090-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL) 60-AM0088-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Calibrator (MAMP 1000 ng/mL) 60-AM0086-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Calibrator (MAMP 500 ng/mL) 60-AM0084-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Reagent Set 60-AM0080-1L | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 1000 Reagent Set 60-AM0080-100 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Level 2 Control (MAMP 625 ng/mL) 60-AM0216-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Level 1 Control (MAMP 375 ng/mL) 60-AM0214-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL) 60-AM0210-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL) 60-AM0208-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL) 60-AM0206-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL) 60-AM0204-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Reagent Set 60-AM0200-1L | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Amphetamines 500 Reagent Set 60-AM0200-100 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Level 2 Control (32 ng/mL) 60-PC0036-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Level 1 Control (18 ng/mL) 60-PC0034-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Calibrator (100 ng/mL) 60-PC0030-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Calibrator (50 ng/mL) 60-PC0028-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Calibrator (25 ng/mL) 60-PC0026-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Calibrator (12.5 ng/mL) 60-PC0024-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Reagent Set 60-PH0020-1L | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Phencyclidine (PCP) Reagent Set 60-PH0020-100 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norfentanyl Level 2 Control (6.25 ng/mL) 60-NF0636-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norfentanyl Level 1 Control (3.75 ng/mL) 60-NF0634-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norfentanyl Calibrator (5 ng/mL) 60-NF0626-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Fentanyl (Qualitative) Reagent Set 60-FN0620-1L | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Fentanyl (Qualitative) Reagent Set 60-FN0620-100 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Level 2 Control (13 ng/mL) 60-NB0552-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine High Calibrator (75 ng/mL) 60-NB0558-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Intermediate Calibrator #2 (40 ng/mL) 60-NB0556-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Intermediate Calibrator #1 (20 ng/mL) 60-NB0554-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Cutoff Calibrator #2 (10 ng/mL) 60-NB0550-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Level 1/Level 2 Control (7 ng/mL) 60-NB0548-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Low/Cutoff Calibrator (5 ng/mL) 60-NB0546-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Norbuprenorphine Level 1 Control (3 ng/mL) 60-NB0544-5 | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Buprenorphine Reagent Set 60-BP0540-1L | 2020-10-05 |
| POINTE SCIENTIFIC, INC. | Pointe Buprenorphine Reagent Set 60-BP0540-100 | 2020-10-05 |
POINTE SCIENTIFIC, INC. | MICROPROTEIN REAGENT SET | 2007-12-04 |
POINTE SCIENTIFIC, INC. | POINTE 360 | 2007-07-13 |
POINTE SCIENTIFIC, INC. | CARBON DIOXIDE LIQUID STABLE REAGENT | 2007-04-30 |
POINTE SCIENTIFIC, INC. | MULTI-ANALYTE CHEMISTRY CALIBRATOR | 2007-04-13 |
POINTE SCIENTIFIC, INC. | AMMONIA/ALCOHOL CONTROL SET | 2007-04-11 |
POINTE SCIENTIFIC, INC. | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | 2007-03-28 |
POINTE SCIENTIFIC, INC. | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | 2005-10-07 |
POINTE SCIENTIFIC, INC. | TOTAL BILIRUBIN REAGENT SET | 2004-06-02 |
POINTE SCIENTIFIC, INC. | HEMOGLOBIN A1C REAGENT SET | 2003-08-06 |
POINTE SCIENTIFIC, INC. | MICROALBUMIN REAGENT SET AND CALIBRATORS | 2003-04-28 |
POINTE SCIENTIFIC, INC. | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | 2003-03-31 |
POINTE SCIENTIFIC, INC. | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | 2002-12-23 |
POINTE SCIENTIFIC, INC. | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | 2000-11-20 |
POINTE SCIENTIFIC, INC. | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | 2000-10-13 |
POINTE SCIENTIFIC, INC. | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET | 1999-12-21 |
POINTE SCIENTIFIC, INC. | AUTOHDL CHOLESTEROL REAGENT SET | 1999-08-05 |
POINTE SCIENTIFIC, INC. | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | 1998-07-22 |
POINTE SCIENTIFIC, INC. | LIQUID ALKALINE PHOSHATASE REAGENT SET | 1997-10-22 |
POINTE SCIENTIFIC, INC. | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | 1997-10-10 |
POINTE SCIENTIFIC, INC. | LIQUID LDH-L REAGENT SET | 1997-10-08 |
POINTE SCIENTIFIC, INC. | ALCOHOL REAGENT SET | 1997-09-25 |
POINTE SCIENTIFIC, INC. | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | 1997-07-22 |
POINTE SCIENTIFIC, INC. | BUN (LIQUID) REAGENT SET | 1997-07-20 |
POINTE SCIENTIFIC, INC. | AUTO HDL CHOLESTEROL CALIBRATOR | 1997-05-23 |
POINTE SCIENTIFIC, INC. | LIQUID GLUCOSE (OXIDASE) REAGENT SET | 1997-04-21 |
POINTE SCIENTIFIC, INC. | URIC ACID (LIQUID) REAGENT SET | 1997-03-11 |
POINTE SCIENTIFIC, INC. | TOTAL IRON (NITRO-PAPS) REAGENT SET | 1996-11-18 |
POINTE SCIENTIFIC, INC. | LACTATE DEHYDROGENASE REAGENT SET | 1996-06-03 |
POINTE SCIENTIFIC, INC. | LIQUID AMYLASE (CNPG3) REAGENT SET | 1994-08-01 |
POINTE SCIENTIFIC, INC. | LIQUID ALT(SGPT) REAGENT SET | 1994-05-03 |
POINTE SCIENTIFIC, INC. | LIQUID AST (SGOT)REAGENT SET | 1994-05-02 |
POINTE SCIENTIFIC, INC. | CREATINE KINASE-MB (CK-MB) REAGENT SET | 1994-01-11 |
POINTE SCIENTIFIC, INC. | LIQUID AMYLASE REAGENT SET | 1993-07-19 |
POINTE SCIENTIFIC, INC. | CREATINE KINASE (CK) REAGENT SET | 1993-03-29 |
POINTE SCIENTIFIC, INC. | POINTE 750 GLYCOMETER | 1992-07-28 |
POINTE SCIENTIFIC, INC. | CALCIUM-ARSENAZO III REAGENT SET | 1992-05-13 |
POINTE SCIENTIFIC, INC. | DIAZO COLORIMETRY, BILIRUBIN | 1991-12-04 |
POINTE SCIENTIFIC, INC. | AMYLASE | 1991-04-30 |
POINTE SCIENTIFIC, INC. | CARBON DIOXIDE REAGENT | 1990-02-23 |
POINTE SCIENTIFIC, INC. | CARBON DIOXIDE REAGENT | 1990-02-01 |
POINTE SCIENTIFIC, INC. | HDL CHOLESTEROL REAGENT | 1989-04-10 |
POINTE SCIENTIFIC, INC. | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | 1987-12-04 |
POINTE SCIENTIFIC, INC. | FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY | 1987-01-21 |
POINTE SCIENTIFIC, INC. | PSI AMYLASE REAGENT | 1987-01-21 |
POINTE SCIENTIFIC, INC. | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | 1986-12-16 |
POINTE SCIENTIFIC, INC. | TRIGLYCERIDES | 1986-07-22 |
POINTE SCIENTIFIC, INC. | GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET | 1986-05-16 |
POINTE SCIENTIFIC, INC. | DIRECT BILIRUBIN | 1986-02-21 |
POINTE SCIENTIFIC, INC. | MAGNESIUM | 1985-09-16 |
POINTE SCIENTIFIC, INC. | CHLORIDE REAGENT | 1985-08-21 |
POINTE SCIENTIFIC, INC. | HEMOGLOBIN | 1985-07-12 |
POINTE SCIENTIFIC, INC. | AMYLASE | 1983-11-25 |
POINTE SCIENTIFIC, INC. | HEXOKINASE, GLUCOSE | 1983-10-14 |
POINTE SCIENTIFIC, INC. | LIPASE HYDROLYSIS/GLYCEROL KINASE | 1983-10-14 |
POINTE SCIENTIFIC, INC. | DIAZO COLORIMETRY, BILLIRUBIN | 1983-09-26 |
POINTE SCIENTIFIC, INC. | CREATININE | 1983-03-24 |
POINTE SCIENTIFIC, INC. | PSI ALBUMIN REAGENT | 1982-09-14 |
POINTE SCIENTIFIC, INC. | PSI INORGANIC PHOSPHORUS | 1982-09-14 |
POINTE SCIENTIFIC, INC. | PSI CALCIUM REAGENT | 1982-09-14 |
POINTE SCIENTIFIC, INC. | PSI TOTAL PROTEIN REAGENT | 1982-09-14 |
POINTE SCIENTIFIC, INC. | LDH-L | 1981-12-31 |
POINTE SCIENTIFIC, INC. | ALT (SGPT) | 1981-12-31 |
POINTE SCIENTIFIC, INC. | CPK(CK) IN VITRO DIAG. REAGENT SET | 1981-12-22 |
POINTE SCIENTIFIC, INC. | AST(SGOT) IN VITRO DIAG. REAGENT SET | 1981-12-22 |
POINTE SCIENTIFIC, INC. | LIPASE | 1981-10-20 |
POINTE SCIENTIFIC, INC. | AMYLASE | 1981-10-06 |
POINTE SCIENTIFIC, INC. | HDL CHOLESTEROL REAGENT | 1981-09-24 |
POINTE SCIENTIFIC, INC. | ALKALINE PHOSPHATASE | 1981-09-09 |
POINTE SCIENTIFIC, INC. | URIC ACID REAGENT SET | 1981-09-09 |
POINTE SCIENTIFIC, INC. | UREA NITROGEN (BUN) | 1981-09-01 |
POINTE SCIENTIFIC, INC. | GAMMA GLUTAMY TRANSPEPTIDASE | 1981-08-31 |
POINTE SCIENTIFIC, INC. | ENZYMATIC TRIGLYCERIDE | 1981-03-31 |
POINTE SCIENTIFIC, INC. | GLUCOSE OXIDASE | 1981-03-31 |
POINTE SCIENTIFIC, INC. | ENZYMATIC CHOLESTEROL | 1981-03-31 |
| NCAGE Code | 1FCJ9 | POINTE SCIENTIFIC, INC. |
| NCAGE Code | 76950 | POINTE SCIENTIFIC INC |
| CAGE Code | 1FCJ9 | POINTE SCIENTIFIC, INC. |
| CAGE Code | 76950 | POINTE SCIENTIFIC INC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2018041233296 | Colombo Harbor,Sri Lanka -> New York/Newark Area, Newark, New Jersey | S.L.A.C.: RETURN EXHIBITION GOODS | 1 PKG |
| 2018030235246 | Shanghai ,China (Mainland) -> Los Angeles, California | OLYMPUS WASH BOTTLE WITH CAP | 80 CTN |
| 2018022835667 | Shanghai ,China (Mainland) -> Los Angeles, California | OLYMPUS WASH BOTTLE WITH CAP | 80 CTN |