FDA Registration
Active
🇺🇸 United States
HORIBA INSTRUMENTS INCORPORATED
Reg #: 1827821
·
FEI: 1827821
·
Expires 2026
Products
98
Proprietary Names
362
Establishment Types
4
Classifications
98
Registration Details
- Registration Name
- HORIBA INSTRUMENTS INCORPORATED
- Registration Number
- 1827821
- FEI Number
- 1827821
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5449 Research Dr
- City
- Canton
- State
- MI
- ZIP
- 48188
- Country
- US
Regulatory Submissions
- 510(k) Number
- K981978
Owner / Operator
- Firm Name
- HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
- Operator Number
- 10083022
- Address
- 9755 Research Drive
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2021-11-23 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2024-03-18 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2021-11-19 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2021-11-22 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2023-07-13 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2021-11-23 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2021-11-19 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2021-11-24 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2021-11-24 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2021-11-23 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2023-01-24 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2023-01-24 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2023-07-13 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Amplifier And Signal Conditioner, Biopotential | DRR | Class 2 | Cardiovascular | No | 2021-11-22 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2023-07-13 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Test, Cystatin C | NDY | Class 2 | Clinical Chemistry | No | 2023-01-24 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2021-11-23 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2021-11-22 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2024-03-18 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2022-06-01 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2022-06-01 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2021-11-23 |
| Saccharogenic, Amylase | CIJ | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Alcohol Control Materials | DKC | Class 1 | Clinical Toxicology | No | 2021-11-23 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Berthelot Indophenol, Urea Nitrogen | CDL | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2021-11-23 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2021-11-24 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2021-12-23 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Albumin, Fitc, Antigen, Antiserum, Control | DDZ | Class 2 | Immunology | No | 2021-11-23 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Meprobamate Test System | QBK | Class 2 | Clinical Toxicology | No | 2021-11-24 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2023-07-13 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2021-11-22 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Standards And Controls, Hemoglobin, Normal And Abnormal | GFS | Class 2 | Hematology | No | 2024-04-10 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2021-11-22 |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | JBF | Class 2 | Hematology | No | 2021-11-22 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2021-11-22 |
| Radioimmunoassay, Corticosterone | CHA | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Whole Blood Hemoglobin Determination | KHG | Class 2 | Hematology | No | 2021-11-19 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2023-07-13 |
| U.V. Method, Cpk Isoenzymes | JHW | Class 2 | Clinical Chemistry | No | 2021-12-08 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2021-11-23 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2024-10-21 |
Proprietary Names
L7574, Pointe autoLDL Cholesterol Reagent
A7516 Pointe Alkaline Phosphatase Reagent
P7516-STD, Pointe Phosphorus Standard
P7516, HP916, Pointe Inorganic Phosphorus Reagent (UV)
C7510, Pointe Cholesterol Reagent
C7509-STD, Pointe Cholesterol Standard
60-MB0748 Pointe Carisporodol Metabolite (SOMA) (200 ng/mL) Intermediate
60-MB0746 Pointe Carisporodol Metabolite (SOMA) Calibrator (100 ng/mL) Cutoff
60-NF0626 Pointe Norfentanyl Calibrator (5 ng/mL)
60-MB0744 Pointe Carisporodol Metabolite (SOMA) Calibrator (50 ng/mL) Low
60-MB0750 Pointe Carisporodol Metabolite (SOMA) (400 ng/mL) High
A7503 Pointe Acid Phosphatase Reagent
T8005, Pointe CMV IgG Enzyme Immunoassay
S1115, Pointe Testosterone Enzyme Immunoassay
A7567 Pointe ASO Reagent
HU982, U7581, Pointe Uric Acid Reagent
S1113, Pointe Progesterone Enzyme Immunoassay
H7546 Pointe Hemoglobin A1c Reagent
H7541 Pointe Hemoglobin A1c Reagent
H7541-CTL Pointe Hemoglobin A1c Controls
H7541-CAL Pointe Hemoglobin A1c Calibrator
G7521 Pointe Liquid Glucose (Oxidase) Reagent
Pointe 180 QT Chemistry Analyzer
Pointe 180 Plus Chemistry Analyzer
Pointe 180 II Chemistry Analyzer
A7504, Pointe Alcohol Reagent
T7535 Pointe Transferrin Reagent
I7517, Pointe Direct TIBC Reagent
C7522 Pointe Liquid Creatine Kinase Reagent (CK)
60-OX0494 Pointe Oxycodone Control (375 ng/mL)
60-OX0484 Pointe Oxycodone Control (75 ng/mL)
60-OX0488 Pointe Oxycodone Control (125 ng/mL)
60-OX0504 Pointe Oxycodone Calibrator (50 ng/mL)
60-OX0490 Pointe Oxycodone Control (225 ng/mL)
60-OX0486 Pointe Oxycodone Calibrator (100 ng/mL)
60-OX0480 Pointe Oxycodone Reagent
60-OX0492 Pointe Oxycodone Calibrator (300 ng/mL)
60-OX0498 Pointe Oxycodone Calibrator (800 ng/mL)
60-OX0496 Pointe Oxycodone Calibrator (500 ng/mL)
M7562-CTL, Pointe Microalbumin Controls
60-HY0774 Pointe Hydrocodone 100 Level 1 Control (75 ng/mL)
60-HY0770 Pointe Hydrocodone 100 Calibrator (300 ng/mL)
60-HY0790 Pointe Hydrocodone 300 Calibrator (800 ng/mL)
60-HY0766 Pointe Hydrocodone 100 Calibrator (100 ng/mL)
60-HY0784 Pointe Hydrocodone 300 Calibrator (150 ng/mL)
60-HY0780 Pointe Hydrocodone 300 Reagent
60-HY0768 Pointe Hydrocodone 100 Calibrator (150 ng/mL)
60-HY0794 Pointe Hydrocodone 300 Level 1 Control (225 ng/mL)
60-HY0786 Pointe Hydrocodone 300 Calibrator (300 ng/mL)
60-HY0796 Pointe Hydrocodone 300 Level 2 Control (375 ng/mL)
60-HY0760 Pointe Hydrocodone 100 Reagent
60-HY0764 Pointe Hydrocodone 100 Calibrator (50 ng/mL)
60-HY0788 Pointe Hydrocodone 300 Calibrator (500 ng/mL)
60-H70776 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL)
H7506-CTL Pointe Hemoglobin Controls
60-AM0216 Pointe Amphetamines 500 Level 2 Control (MAMP 625 ng/mL)
60-AM0206 Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL)
60-AM0204 Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL)
60-AM0208 Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL)
60-AM0210 Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL)
60-AM0200 Pointe Amphetamines 500 Reagent
60-AM0214 Pointe Amphetamines 500 Level 1 Control (MAMP 375 ng/mL)
L7572, HL956, Pointe Lactate Dehydrogenase Reagent (LD)
60-MA1796 Pointe Multi-Analyte Set E DAU Level 2 Control
60-MA1754 Pointe Multi-Analyte Set D Urine DAU Level 1 Control
60-MA1756 Pointe Multi-Analyte Set D Urine DAU Level 2 Control
60-MA1794 Pointe Multi-Analyte Set E DAU Level 1 Control
C7529 Pointe Calcium Arsenazo III Reagent
G7540-STD, Pointe Glycohemoglobin Standard
G7540-CTL, Pointe Glycohemoglobin Controls
A7526 Pointe Liquid ALT (SGPT) Reagent
P1035, Pointe Immunoglobulin E (IgE) Enzyme Immunoassay (EIA)
H7588-CAL B-Hydroxbutyrate Calibrator
H7588-CTL B-Hydroxybutyrate Controls
H7588 B-Hydroxybutyrate Reagent
A7505 Pointe Alkaline Phosphatase Reagent
T1005, Pointe Triiodothyronine (T3) Enzyme Immunoassay (EIA)
Pointe Impulse Chemistry Analyzer
L7513-CTL Lipase Controls
L7513 Lipase Reagent
L7513-STD Lipase Standard
B7552 Pointe Liquid Urea Nitrogen (BUN) Reagent
RA502-CTL Pointe RF/ASO Controls
C7502 Pointe Carbon Dioxide Reagent
C7502-STD Pointe Carbon Dioxide Standard
CM1117, Pointe Myoglobin Enzyme Immunoassay (EIA)
T7535-CAL Pointe Transferrin Calibrators
60-MA1706 Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator
60-MA1708 Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator
60-MA1704 Pointe Multi-Analyte Set C Urine Low Calibrator
60-MA1716 Pointe Multi-Analyte Set C Urine DAU Level 2 Control
60-UN0002 Pointe Universal Negative Calibrator
60-MA1710 Pointe Multi-Analyte Set C Urine DAU High Calibrator
60-MA1714 Pointe Multi-Analyte Set C Urine DAU Level 1 Control
T1007, Pointe Total Thyroxine (T4) Enzyme Immunoassay (EIA)
60-MA1782 Pointe Multi-Analyte Set E DAU Negative Calibrator
60-MA1742 Pointe Multi-Analyte Set D Urine DAU Negative Calibrator
60-MA1748 Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator
60-MA1744 Pointe Multi-Analyte Set D Urine DAU Low Calibrator
60-MA1784 Pointe Multi-Analyte Set E DAU Low Calibrator
60-MA1790 Pointe Multi-Analyte Set E DAU High Calibrator
60-MA1786 Pointe Multi-Analyte Set E DAU Cutoff Calibrator
60-MA1746 Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator
60-MA1750 Pointe Multi-Analyte Set D Urine DAU High Calibrator
60-MA1788 Pointe Multi-Analyte Set E DAU Intermediate Calibrator
60-OP0040 Pointe Opiate 300 Reagent
Mindray BS480 Chemistry Analyzer
Yumizen C560 Chemistry Analyzer
C7585-CAL Cystatin C Calibrator
C7585-CTL Cystatin C Controls
C7585 Cystatin C Reagent
T8004, Pointe Rubella IgM Enzyme Immunoassay
B7576 Pointe Total Bilirubin Reagent
A7504-STD, Pointe Alcohol Standard
60-CC0060 Pointe Cocaine Metabolite Reagent
A7567 Pointe ASO Calibrator
G7571, HG959, Pointe GGT (y-glutamyl transferase) Reagent
Pointe Lipid Control Set
LPA400C Lipoprotein (a) Calibrator
LPA400CR Lipoprotein (a) Calibrator
LPA400 Lipoprotein (a)
A7527 ALT Single Reagent
F1031, Pointe Luteinizing Hormone (LH) Enzyme Immunoassay
T7531, T7532, Pointe Triglyceride (GPO) Reagent
T1008, Pointe Free Thyroxine (fT4) Enzyme Immunoassay (EIA)
T8001, Pointe Toxoplasma IgG Enzyme Immunoassay
A7564, Pointe Liquid Amylase (CNPG3) Reagent
T7535-CTL Pointe Transferrin Controls
C7562-CTL, Pointe CK-MB Controls
B7554 Pointe BUN Reagent
Mindray BA800 Chemistry Analyzer
H7511, Pointe HDL Cholesterol Precipitating Reagent
ABX Minotrol 16 Whole Blood Hematology Controls (5300100303, 5300100306, 5300100312) BFTROL
T8002, Pointe Toxoplasma IgM Enzyme Immunoassay
C7548, Pointe Creatinine (Enzymatic) Reagent
60-EA0440 Pointe Ethyl Alcohol Reagent
60-EA0448 Pointe Ethyl Alcohol Level 1 Control (50 mg/dL)
60-EA0450 Pointe Ethyl Alcohol Level 2 Control (300 mg/dL)
60-EA0446 Pointe Ethyl Alcohol Calibrator (100 mg/dL)
T7531-STD, Pointe Triglyceride Standard
G7540, Pointe Glycohemoglobin Reagent
I7517-CAL, Pointe Direct TIBC Calibrator
T1001, Pointe Thyroid Stimulating Hormone (TSH) Enzyme Immunoassay (EIA)
B7551, Pointe Urea Nitrogen (BUN) (Berthelot/Colorimetric)
HB979 Pointe Total Bilirubin Reagent
HB936 Pointe Direct Bilirubin Reagent
60-FN0620 Pointe Fentanyl (Qualitative) Reagent
U7580-STD, Pointe Uric Acid Standard
U7580, Pointe Uric Acid Reagent
F1037, Pointe Prolactin Immunoassay
C7506-DIL Pointe Chemistry Diluent
C7506-CAL Pointe Chemistry Calibrator
G7517, Pointe Glucose (Hexokinase) Reagent
H7545, Pointe Liquid autoHDL Choldesterol Reagent
H7545-CAL, Pointe autoHDL/LDL Cholesterol Calibrator
60-PH0020 Pointe Phencyclidine Reagent
A7504-CTL, Pointe Ammonia / Alcohol Control Set
T1006 Pointe Free T3 EIA
60-NB0546 Pointe Norbuprenorphine Low/Cutoff Calibrator (5 ng/mL)
60-NB0556 Pointe Norbuprenorphine Intermediate Calibrator #2 (40 ng/mL)
60-NB0548 Pointe Norbuprenorphine Level 1/Level 2 Control (7 ng/mL)
60-NB0544 Pointe Norbuprenorphine Level 1 Control (3 ng/mL)
60-NB0550, Pointe Norbuprenorphine Cutoff Calibrator #2 (10 ng/mL)
60-NB0554 Pointe Norbuprenorphine Intermediate Calibrator #1 (20 ng/mL)
60-BP0540, Pointe Buprenorphine Reagent
60-NB0558 Pointe Norbuprenorphine High Calibrator (75 ng/mL)
60-NB0552 Pointe Norbuprenorphine Level 2 Control (13 ng/mL)
A7502 Pointe Albumin Reagent
A7502-STD Pointe Albumin Standard
Mindray BS200 Chemistry Analyzer
Pointe C2000 Chemistry Analyzer
60-BZ0266 Pointe Benzodiazepine Calibrator/Control (Oxazepam 200 ng/mL)
60-BZ0272 Pointe Benzodiazepine Control (Oxazepam 400 ng/mL)
60-BZ0264 Pointe Benzodiazepine Calibrator/Control (Oxazepam 100 ng/mL)
60-BZ0260 Pointe Benzodiazepine Reagent
60-BZ0268 Pointe Benzodiazepine Calibrator/Control (Oxazepam 300 ng/mL)
60-BZ0270 Pointe Benzodiazepine Calibrator (Oxazepam 1000 ng/mL)
T7528-STD Pointe Total Protein Standard
T7528, HT928, Pointe Total Protein (Biuret) Reagent
L7596, Pointe Lactate Reagent
L7596-STD, Pointe Lactate Standard
60-EC0334 Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1
60-EC0330 Pointe Ecstasy (MDMA) Calibrator (1000 ng/mL) High
60-EC0324 Pointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low
60-EC0336 Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2
60-EC0320 Pointe Ecstasy (MDMA) Reagent
60-EC0328 Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate
60-EC0326 Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff
H7575-CTL, Pointe Homocysteine Controls
60-MP0708 Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate
60-MP0700 Pointe Methamphetamine Reagent
60-MP0710 Pointe Methamphetamine Calibrator (2000 ng/mL) High
60-MP0716 Pointe Methamphetamine Control (625 ng/mL) Level 2
60-MP0706 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff
60-MP0714 Pointe Methamphetamine Control (375 ng/mL) Level 1
60-MP0704 Pointe Methamphetamine Calibrator (250 ng/mL) Low
H7575, Pointe Homocysteine Reagent
H7575-CAL, Pointe Homocysteine Calibrator
A7562 Pointe AST Single Reagent
C7504-STD, Carbon Dioxide Standard
60-ME0224 Pointe Methadone Calibrator (150 ng/mL)
60-PP0256 Pointe Propoxyphene Control (375 ng/mL) Level 2
60-ME0226 Pointe Methadone Calibrator (300 ng/mL)
60-ME0234 Pointe Methadone Level 1 Control (225 ng/mL)
60-PP0254 Pointe Propoxyphene Control (225 ng/mL) Level 1
60-PP0250 Pointe Propoxyphene Calibrator (1000 ng/mL) High
60-PP0244 Pointe Propoxyphene Calibrator (150 ng/mL) Low
60-PP0248 Pointe Propoxyphene Calibrator (600 ng/mL) Intermediate
60-ME0230 Pointe Methadone Calibrator (1000 ng/mL)
60-ME0228 Pointe Methadone Calibrator (600 ng/mL)
60-ME0236 Pointe Methadone Level 2 Control (375 ng/mL)
60-PP0246 Pointe Propoxyphene Calibrator (300 ng/mL) Cutoff
CM1105, Pointe Troponin I (Human Cardiac Specific) EIA Test Kit
M7562-CAL, Pointe Microalbumin Multi-Calibrator
M7562, Pointe Microalbumin Reagent
60-ME0220 Pointe Methadone Reagent
F1029, Pointe Follicle-Stimulation Hormone (FSH) Enzyme Immunoassay
60-BA0286 Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL)
60-BA0290 Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL)
60--BA0288 Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL)
60-BA0292 Pointe Barbiturate Control (Secobarbital 400 ng/mL)
60-BA0280 Pointe Barbiturate Reagent
60-BA0284 Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL)
60-TH0148 Pointe THC Control (31.25 ng/mL)
60-CA0140 Pointe Cannabinoid (THC) Reagent
60-TH0004 Pointe THC Negative Calibrator (0 ng/mL)
60-TH0014 Pointe THC Calibrator/Control (37.5 ng/mL)
60-TH0152 Pointe THC Calibrator/Control (75 ng/mL)
60-TH0016 Pointe THC Control (62.5 ng/mL)
60-TH0144 Pointe THC Calibrator (12.5 ng/mL)
60-TH0146 Pointe THC Calibrator (25 ng/mL)
60-TH0154 Pointe THC Calibrator (100 ng/mL)
60-TH0158 Pointe THC Calibrator (200 ng/mL)
60-TH0012 Pointe THC Control (18.75 ng/mL)
60-TH0150 Pointe THC Calibrator (50 ng/mL)
60-TH0018 Pointe THC Control (125 ng/mL)
60-TH0156 Pointe THC Calibrator (150 ng/mL)
60-CM0740 Pointe Carisporodol Metabolite (SOMA) Reagent
B7550-STD Pointe BUN Standard
HM929, Pointe Magnesium Reagent
M7527-STD, Pointe Magnesium Standard
R7502 Pointe Rheumatoid Factor (RF) Reagent
R7502-CAL Pointe Rheumatoid Factor (RF) Calibrators
60-MM0384 Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low
60-MM0406 Pointe Methadone Metabolite (EDDP) Calibrator (100 ng/mL) Cutoff
60-MM0386 Pointe Methadone Metabolite (EDDP) Calibrator (300 ng/mL) Cutoff
60-MM0388 Pointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate
60-MM0380 Pointe Methadone Metabolite (EDDP) Reagent
60-MM0408 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate
60-MM0404 Pointe Methadone Metabolite (EDDP) Calibrator (50 ng/mL) Low
60-MM0390 Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High
60-MM0410 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High
S1111, Pointe Estradiol (E2) Enzyme Immunoassay
T1003, Pointe Ultra-Sensitive Thyroid Stimulating Hormone (U-TSH) EIA
L7580-CTL, Pointe Lipid Controls
B7538, Pointe Direct Bilirubin Reagent
60-PP0240 Pointe Propoxyphene Reagent
C7513-STD Pointe Creatinine Standard
C7539 Pointe Creatinine Reagent
F1027, Pointe Human Chorionic Gonadotropin (hCG) EIA Test Kit
H7590, HDL Reagent
C7592, Pointe Chemistry Controls, Level 1 and Level 2
C7591, Pointe Chemistry Control, Level 2
C7590, Pointe Chemistry Control, Level 1
L7597, Pointe Lipoprotein (a) Reagent
60-OP0664 Pointe Opiate 2000 Calibrator (Morphine 1000 ng/mL)
60-OP0674 Pointe Opiate 2000 Level 1 Control (Morphine 1500 ng/mL)
60-OP0668 Pointe Opiate 2000 Calibrator (Morphine 4000 ng/mL)
60-OP0670 Pointe Opiate 2000 Calibrator (Morphine 6000 ng/mL)
60-OP0660 Pointe Opiate 2000 Reagent
60-OP0666 Pointe Opiate 2000 Calibrator (Morphine 2000 ng/mL)
60-OP0676 Pointe Opiate 2000 Level 2 Control (Morphine 2500 ng/mL)
H7505-STD, Hemoglobin Standard
60-AM0086 Pointe Amphetamines 1000 Calibrator (MAMP 1000 ng/mL)
60-PC0034 Pointe Phencyclidine Level 1 Control (18 ng/mL)
60-PC0036 Pointe Phencyclidine Level 2 Control (32 ng/mL)
60-OP0056 Pointe Opiate Level 2 Control (Morphine 375 ng/mL)
60-OP0048 Pointe Opiate Calibrator (Morphine 600 ng/mL)
60-CC0064 Pointe Cocaine Calibrator (BE 150 ng/mL)
60-AM0090 Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL)
60-OP0044 Pointe Opiate Calibrator (Morphine 150 ng/mL)
60-OP0046 Pointe Opiate Calibrator (Morphine 300 ng/mL)
60-AM0084 Pointe Amphetamines 1000 Calibrator (MAMP 500 ng/mL)
60-CC0068 Pointe Cocaine Calibrator (BE 1000 ng/mL)
60-PC0030 Pointe Phencyclidine Calibrator (100 ng/mL)
60-CC0076 Pointe Cocaine Level 2 Control (BE 375 ng/mL)
60-CC0074 Pointe Cocaine Level 1 Control (BE 225 ng/mL)
60-PC0026 Pointe Phencyclidine Calibrator (25 ng/mL)
60-AM0088 Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL)
60-PC0024 Pointe Phencyclidine Calibrator (12.5 ng/mL)
60-OP0050 Pointe Opiate Calibrator (Morphine 1000 ng/mL)
60-AM0094 Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL)
60-CC0066 Pointe Cocaine Calibrator (BE 300 ng/mL)
60-AM0096 Pointe Amphetamines 1000 Level 2 Control (MAMP 1250 ng/mL)
60-CC0070 Pointe Cocaine Calibrator (BE 3000 ng/mL)
60-PC0028 Pointe Phencyclidine Calibrator (50 ng/mL)
60-OP0054 Pointe Opiate Level 1 Control (Morphine 225 ng/mL)
H7587, Pointe B-Hydroxybutyrate Reagent
H7587-STD, Pointe B-Hydroxybutyrate Standard
H7587-CTL, Pointe B-Hydroxybutyrate Controls
A7561 Pointe Aspartate Aminotransferase (AST) Reagent
C7568-CTL, Pointe CRP(HS) Wide Range Controls
G7583-CTL, Pointe G6PD Controls
G7583, Pointe Glucose-6-Phosphate Dehydrogenase Reagent (G6PD)
G7583-LYS, Pointe G6PD Lyse
A7553-STD, Pointe Ammonia Standard
A7553, Pointe Ammonia Reagent
I7505-STD, I7513-STD Pointe Iron Standard
I7506, Pointe UIBC Buffer
I7504, I7505, HI904, Pointe Total Iron Reagent
S1887, Pointe Cortisol Enzyme Immunoassay
60-CC0696 Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL)
60-CC0680 Pointe Cocaine Metabolite 150 Reagent
60-CC0684 Pointe Cocaine Metabolite 150 Calibrator (BE 75 ng/mL)
60-CC0688 Pointe Cocaine Metabolite 150 Calibrator (BE 300 ng/mL)
60-CC0694 Pointe Cocaine Metabolite 150 Level 1 Control (BE 112.5 ng/mL)
60-CC0690 Pointe Cocaine Metabolite 150 Calibrator (BE 1000 ng/mL)
60-CC0686 Pointe Cocaine Metabolite 150 Calibrator (BE 150 ng/mL)
H7506-STD Pointe Hemoglobin Standard
H7504 Pointe Hemoglobin Reagent
C7503, HC902 Pointe Calcium Reagent
C7053-STD Pointe Calcium Standard
F7505-CAL Pointe Ferritin Calibrators
F7505-CTL Pointe Ferritin Controls
F7505 Pointe Ferritin Reagent
HA965, Pointe Amylase (EPS-G7) Reagent
T8006, Pointe CMV IgM Enzyme Immunoassay
L7503 Pointe Lipase (Colormetric) Reagent
T8003, Pointe Rubella IgG Enzyme Immunoassy
G7518-STD Pointe Glucose Oxidase Standard
C7563 Pointe Creatine Kinase-MB (CK-MB) Reagent (2pt liquid)
C7562 Pointe Creatine Kinase-MB (CK-MB) Reagent (Powder)
C7568, Pointe C-Reactive Protein High Sensitivity CRP (HS)
C7568-STD, Pointe CRP(HS) Wide Range Multi-Standard
C7568-CAL, Pointe CRP(HS) Wide Range Multi-Calibrator
T8007, Pointe HSV IgG Enzyme Immunoassay
60-MB0756 Pointe Carisporodol Metabolite (SOMA) Control (125 ng/mL) Level 2
60-MM0396 Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2
60-MM0416 Pointe Methadone Metabolite (EDDP) Control (125 ng/mL) Level 2
60-NF0636 Pointe Norfentanyl Level 2 Control (6.25 ng/mL)
60-NF0634 Pointe Norfentanyl Level 1 Control (3.75 ng/mL)
60-MB0754 Pointe Carisporodol Metabolite (SOMA) Control (75 ng/mL) Level 1
60-MM0414 Pointe Methadone Metabolite (EDDP) Control (75 ng/mL) Level 1
60-MM0394 Pointe Methadone Metabolite (EDDP) Control (225 ng/mL) Level 1
COC150, Pointe Cocaine Metabolite Reagent
P7582-STD, Pointe Microprotein Standard
P7582, Pointe Microprotein Reagent
60-AC0598 Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative
60-AC0586 Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff
60-AC0588 Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate
60-AC0580 Pointe 6-Acetylmorphine Reagent
60-AC0594 Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1
60-AC0596 Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2
60-AC0584 Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low
60-AC0590 Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High
ABX Minocal Whole Blood Hematology Calibrator (5300100300)
60-AM0080 Pointe Amphetamines 1000 Reagent
L7597-CAL, Pointe Lipoprotein (a) Calibrator
L7597-CTL, Pointe Lipoprotein (a) Control
P1025, Pointe Ferritin Enzyme Immunoassy (EIA)
H7512-STD, Pointe HDL Cholesterol Standard
H7507, Pointe HDL Cholesterol Precipitating Reagent (Dextran Sulfate)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility