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FDA-Registered Company Profile for ABBOTT LABORATORIES
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| FDA-Supplied Establishment Information: |
|
| Establishment Registration Number: |
1415939 |
| Company Name: |
ABBOTT LABORATORIES |
| Address: |
100 AND 200 ABBOTT PARK RD. |
| Address 2: |
|
| City: |
ABBOTT PARK |
| State |
IL |
| Zip / Postal Code: |
60064-3500 |
| County: |
LAKE |
| Country: |
US |
| Establishment Operation Code(s): |
AA - Initial Distributor
MM - Manufacturer
MS - Specification Developer
|
| Establishment Status Code: |
A -
Active
|
Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
1415939 |
| Company Name: |
ABBOTT LABORATORIES
|
| Address: |
100 AND 200 ABBOTT PARK RD. |
| Address 2: |
|
| City: |
ABBOTT PARK |
| State: |
IL |
| Zip / Postal Code: |
60064-3500 |
| Country: |
US |
| Owner/Operator Phone: |
847-937-6100
|
| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MS KIM SHAW |
| Company Name: |
ABBOTT LABORATORIES |
| Address: |
100 ABBOTT PARK RD. |
| Address 2: |
D-3QA/AP6C-1 |
| City: |
ABBOTT PARK |
| State: |
IL |
| Zip / Postal Code: |
60064 6088 |
| Country: |
US |
| Official Corespondent Phone Number: |
847-938-3471
|
 |
 |
| Other Establishment Information: |
| Establishment Phone: |
|
| Fax: |
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| General Email: |
|
| Web Site: |
http://www.abbott.com
|
| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
|
| About Us: |
|
| Differentiation: |
|
FDA-Registered Products Offered by ABBOTT LABORATORIES
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|
Common Device Name |
Proprietary Device Name |
| 1 |
ALDOSTERONE RIA DIAGNOSTIC KIT |
ALDOSTERONE RIA DIAGNOSTIC KIT |
| 2 |
ALPHA-FETOPROTEIN |
MULTIPLE PRODUCT NAMES |
| 3 |
AMIKACIN |
TDX/TDXFLX AMIKACIN |
| 4 |
AMNIOCENTESIS TRAY |
AMNIOCENTESIS TRAY |
| 5 |
ASSAY FOR DETECTION OF CREATINE KINASE |
IMX STAT CK-MB |
| 6 |
ASSAY FOR DETECTION OF CREATINE KINASE |
AXSYSM CK-MB |
| 7 |
BARBITURATES |
MULTIPLE PRODUCT NAMES |
| 8 |
BENZODIAZEPINE |
MULTIPLE PRODUCT NAMES |
| 9 |
BLOOD WARMING COIL |
BLOOD WARMING COIL |
| 10 |
C-REACTIVE PROTEIN OR CRP |
MULTIPLE PRODUCT NAMES |
| 11 |
CANNABINOIDS |
MULTIPLE PRODUCT NAMES |
| 12 |
CARBOHYDRATE ANTIGEN (CA19-9) |
ARCHITECT CA19-9 |
| 13 |
CARDIAC OUTPUT MONITOR |
CARDIAC OUTPUT MONITOR |
| 14 |
CATHETER, INTRAVASCULAR, DIAGNOSTIC |
MULTIPLE PRODUCT NAMES |
| 15 |
COCAINE |
MULTIPLE PRODUCT NAMES |
| 16 |
CORTISOL |
TDX CORTISOL |
| 17 |
CRIMPING TOOL |
CRIMPING TOOL |
| 18 |
CYCLOSPORINE |
AXSYM CYCLOSPORINE |
| 19 |
CYTOMEGALOVIRUS OR CMV |
AXSYM CMV |
| 20 |
DEVICE, SPECIMEN COLLECTION |
DEVICE, SPECIMEN COLLECTION |
| 21 |
DIGITOXIN |
MULTIPLE; AXSYM DIGITOXIN, TDX FLX DIGITOXIN |
| 22 |
DIGOXIN |
MULTIPLE PRODUCT NAMES |
| 23 |
DRUG MONITORING AND IMMUNE FLUOROMETRIC SYSTEM |
MULTIPLE PRODUCT NAMES |
| 24 |
ENZYME ASSAY TO DETECT VITAMIN B12 IN HUMAN SERUM OR PLASMA |
IMX B12 |
| 25 |
ENZYME IMMUNOASSAY FOR THE MEASUREMENT OF PROSTATIC ACID PHOSPHATASE (PAP) |
ABBOTT PAP-EIA |
| 26 |
ENZYME IMMUNOASSAY FOR THE RAPID DETECTION AND CONFIRMATION OF GROUP A STREPTOCO |
MULTIPLE PRODUCT NAMES |
| 27 |
ENZYME IMMUNOASSAY TO MEASURE CA 15-3 IN HUMAN SERUM OR PLASMA |
MULTIPLE PRODUCT NAMES |
| 28 |
ENZYME IMMUNOASSAY TO MEASURE CA125 IN HUMAN SERUM |
MULTIPLE PRODUCT NAMES |
| 29 |
ENZYME IMMUNOASSAY TO MEASURE IGM ANTIBODIES TO RUBELLA |
AXSYM RUBELLA IGM |
| 30 |
ENZYME IMMUNOASSAYS FOR DIAGNOSIS & MONITORING OF HEPATITIS |
MULTIPLE PRODUCT NAMES |
| 31 |
EPIDURAL CATHETER |
EPIDURAL CATHETER |
| 32 |
ERYTHROMYCIN SUSCEPTIBILITY DISCS NDC#0074-8229-00 |
ERYTHROCIN SENSITIVITY DISCS |
| 33 |
ESTRADIOL |
AXSYM ESTRADIOL |
| 34 |
ETHANOL |
TDX/TDXFLX/ADX ETHANOL |
| 35 |
ETHANOL |
MULTIPLE PRODUCT NAMES |
| 36 |
ETHOSUXIMIDE |
TDX/TDXFLX ETHOSUXIMIDE |
| 37 |
FERRITIN |
MULTIPLE PRODUCT NAMES |
| 38 |
FERRITIN |
IMX FERRITIN |
| 39 |
FERULES |
FERULES |
| 40 |
FETAL LUNG MATURITY |
TDX FETAL LUNG MATURITY |
| 41 |
FLUORESCENCE POLARIZATION IMMUNOASSAY (FPIA) FOR THE QUANTITAVIVE DETERMINATION |
IMX T4 |
| 42 |
FLUORESCENCE POLARIZATION IMMUNOASSAY TO QUANTITATE CYCLOSPORINE IN HUMAN WHOLE |
MULTIPLE PRODUCT NAMES |
| 43 |
FOLLICLE STIMULATING HARMONE |
MULTIPLE PRODUCT NAMES |
| 44 |
FREE PHENYTOIN |
TDXTDXFLXFREE PHENYTOIN II |
| 45 |
FREE PSA |
MULTIPLE: ARCHITECT/AXSYM/IMX FREE PSA |
| 46 |
GENTAMICIN |
ASXYM GENTAMICIN |
| 47 |
GENTAMICIN |
TDX / TDX FLX GENTAMICIN |
| 48 |
HEMAGGLUTINATION INHIBITION TEST FOR ANTIBODY TO RUBELLA VIRUS |
RUBA-TECT |
| 49 |
HEPATITIS C VIRUS |
HCV 2.0 EIA |
| 50 |
HUMAN CHORIONIC GONADOTROPIN |
ARCHITECT TOTAL B-HCG |
| 51 |
HYSTEROSCOPIC FLUID |
DEXTRAN HM 32% |
| 52 |
I.V. STAND AND ACCESSORIES |
MULTIPLE PRODUCT NAMES |
| 53 |
IMMUNOASSAY USED TO DETECT HCG IN HUMAN SERUM |
ABBOTT HCG SERUM CONTROLS |
| 54 |
IN VITRO REAGENT TO DETERMINE TACROLIMUS IN BLOOD |
IMX TACROLIMUS (II) |
| 55 |
IN-VITRO ENZYME IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HUMAN |
ABBOTT HTLV-I/HTLV-II EIA |
| 56 |
INSULIN ASSAY |
IMX INSULIN |
| 57 |
INTRAVASCULAR CATHETER |
DRUM CARTRIDGE CATHETER |
| 58 |
ION CAPTURE ASSAY FOR THE QUANTITATIVE DETERMINATION OF FOLATE IN HUMAN SERUM, R |
ABBOTT AXSYM FOLATE |
| 59 |
IRRIGATION SET |
TIDAL DISTENSION SET, LARGE BORE Y-IRRIGATION SET AND LARGE BORE Y-IRRIGATION |
| 60 |
IRRIGATION SET FOR ARTHROSCOPIC PROCEDURES |
LARGE BORE Y-IRRIGATION SET |
| 61 |
LIDOCAINE |
TDX/TDXFLXLIDOCAINE |
| 62 |
METHADONE |
MULTIPLE PRODUCT NAMES |
| 63 |
METHOTREXATE |
TDX/TDXFLX METHOTREXATE |
| 64 |
MICROPARTICLE ENZYME IMMUNOASSAY FOR THE QUANTATATIVE DETERMINATION OF CARDIAC T |
AXSYM TROPONIN-I |
| 65 |
MYGLOBIN |
AXSYM MYOGLOBIN |
| 66 |
NETILMICIN |
TDX/TDX FLX NETILMICIN |
| 67 |
NUCLEIC ACID TEST TO DETECT HCV |
LCX HCV RNA QUANTITATIVE ASSAY |
| 68 |
NUCLEIC ACID TEST TO DETECT HIV |
LCX HIV RNA QUANTITATIVE ASSAY |
| 69 |
OPIATES |
MULTIPLE PRODUCT NAMES |
| 70 |
PCP |
MULTIPLE PRODUCT NAMES |
| 71 |
PERITONEAL DIALYSIS SOLUTIN ADMIN, SET (STERILE) |
INPERSOL SET |
| 72 |
PERITONEAL DIALYSIS TRAY (STERILE) |
PERITONEAL DIALYSIS TRAY |
| 73 |
PHENYTOIN |
MULTIPLE PRODUCT NAMES |
| 74 |
PRIMARY CALIBRATORS |
MULTIPLE PRODUCT NAMES |
| 75 |
PRIMIDONE |
TDX / TDX F/X PRIMIDONE |
| 76 |
PROCAINAMIDE |
MULTIPLE; AXSYM PROCAINAMIDE; TDX/TDXFLX PROCAINAMIDE |
| 77 |
PROGESTERONE |
MULTIPLE PRODUCT NAMES |
| 78 |
PROPOXYPHENE |
MULTIPLE PRODUCT NAMES |
| 79 |
PSA |
MULTIPLE: AXSYM PSA, IMX PSA |
| 80 |
QUALITATIVE IMMUNOASSAY FOR THE DETECTION OF HIV-1 P24 ANTIGEN IN HUMAN SERUM |
HIVAG-1 MONOCLONAL BLOCKING ANTIBODY |
| 81 |
QUINIDINE ASSAYS (VARIOUS) |
TDX/TDX FLX QUINIDINE, AXSYM QUINIDINE |
| 82 |
RADIOIMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF GASTRIN IN SERUM |
GASTRIN RIA |
| 83 |
RADIOIMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF HUMAN THYROID STIMULATING |
HTSH RIABEAD |
| 84 |
RADIOIMMUNOASSAY FOR THE QUANTITATIVE MEASUREMENT OF B2-MICROGLOBULIN RIA INHUMA |
ABBOTT B - 2 - MICROGLOBULIN RIA |
| 85 |
RECEPTAL A.T.S. MEDIASTINAL LINER |
RECEPTAL A.T.S. MEDIASTINAL LINER |
| 86 |
SHIELDED BLUNT CANNULA |
SHIELDED BLUNT CANNULA |
| 87 |
SULFOLITHOCHOLYLGLYCINE RADIOIMMUNOASSAY DIAGNOSTIC KIT |
SLCG RIA DIAGNOSTIC KIT |
| 88 |
T3 UPTAKE OR T-UPTAKE |
MULTIPLE: IMX T-UPTAKE, AXSYM T-UPTAKE |
| 89 |
TESTOSTERONE |
ARCHITECT TESTOSTERONE |
| 90 |
THEOPHYLLINE |
MULTIPLE PRODUCT NAMES |
| 91 |
THORACENTESIS SET |
THORACENTESIS SET |
| 92 |
THREE-WAY STOPCOCK WITH MALE LOCKING LUER ADA |
MULTIPLE PRODUCT NAMES |
| 93 |
TOBRAMYCIN |
TDX/ TDX FLX, TOBRAMYCIN |
| 94 |
TOBRAMYCIN |
AX SYM TOBRAMYCIN |
| 95 |
TOTAL PSA |
MULTIPLE: ARCHITECT/AXSYM/IMX TOTAL PSA |
| 96 |
VARIOIUS ASSAYS FOR DETECTION OF SGPT (ALT) |
MULTIPLE PRODUCT NAMES |
| 97 |
VARIOUS STATION, PIPETTING AND DILUTING, FOR CLINICAL USE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 98 |
VARIOUS ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 99 |
VARIOUS RADIOIMMUNOASSAY, FREE THYROXINE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 100 |
VARIOUS RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 101 |
VARIOUS TEST, CARBOHYDRATE ANTIGEN (CA19-9) PRODUCTS |
ARCHITECT CA 19-9 |
| 102 |
VARIOUS ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 103 |
VARIOUS COMPUTERS AND SOFTWARE, MEDICAL PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 104 |
VARIOUS ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS PRODUCTS |
TESTPACK RSV |
| 105 |
VARIOUS APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED PRODUCTS |
RECEPTAL LINER |
| 106 |
VARIOUS ACID, LACTIC, ENZYMATIC METHOD PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 107 |
VARIOUS ADAPTOR, CATHETER PRODUCTS |
MALE ADAPTER PLUG |
| 108 |
VARIOUS SYSTEM, THERMAL REGULATING PRODUCTS |
THERMOSET SYSTEM |
| 109 |
VARIOUS SET, ADMINISTRATION, INTRAVASCULAR PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 110 |
VARIOUS TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 111 |
VARIOUS LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 112 |
VARIOUS CLAMP, LINE PRODUCTS |
CLAMP |
| 113 |
VARIOUS INTRODUCER, CATHETER PRODUCTS |
INTRODUCER |
| 114 |
VARIOUS SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 115 |
VARIOUS ACETAMENOPHEN ASSAYS |
MULTIPLE: AXSYM, TDX/TDX FLX/ADX ACETAMINOPHLEN |
| 116 |
VARIOUS AMPHETAMINE ASSAYS |
MULTIPLE; AXSYM/TDXFLX/ADX AMPTIETAMINE/METHAMPHETAMINE |
| 117 |
VARIOUS ANESTHESIA KITS (STERILE) |
MULTIPLE PRODUCT NAMES |
| 118 |
VARIOUS ASSAY FOR DTECTION OF CREATINE KINASE |
MULTIPLE PRODUCT NAMES |
| 119 |
VARIOUS ASSAYS FOR DETECTION OF CARBAMAZEPINE |
MULTIPLE PRODUCT NAMES |
| 120 |
VARIOUS ASSAYS FOR DETECTION OF GGTP |
MULTIPLE PRODUCT NAMES |
| 121 |
VARIOUS ASSAYS FOR DETECTION OF PHENOBARBITAL |
MULTIPLE PRODUCT NAMES |
| 122 |
VARIOUS ASSAYS FOR DETECTION OF PHENYTOIN |
MULTIPLE PRODUCT NAMES |
| 123 |
VARIOUS ASSAYS FOR DETECTION OF THEOPHYLLINE |
MULTIPLE PRODUCT NAMES |
| 124 |
VARIOUS ASSAYS FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN |
MULTIPLE PRODUCT NAMES |
| 125 |
VARIOUS ASSAYS FOR TOXOPLASMA GONDII |
MULTIPLE: AXSYM TOXO; IMX TOXO |
| 126 |
VARIOUS ASSAYS TO DETECT CHLAMYDIA TRACHOMATIS |
MULTIPLE PRODUCT NAMES |
| 127 |
VARIOUS CONTINUOUS FLUSH DEVICES |
MULTIPLE PRODUCT NAMES |
| 128 |
VARIOUS ESTRIOL ASSAYS |
MULTIPLE: TDX/TDX FLX FREE AND TOTAL ESTRIOL ASSAYS |
| 129 |
VARIOUS FERRITIN ASSAYS |
MULTIPLE: ARCHITECT, AXSYM, IMX FERRITIN |
| 130 |
VARIOUS FIBEROPTIC OXIMETER CATHETERS |
MULTIPLE PRODUCT NAMES |
| 131 |
VARIOUS HCG, BETA-HCG, TOTAL BETA-HCG ASSAYS |
MULTIPLE ARCHITECT, AXSYM, IMX, TEST PACK |
| 132 |
VARIOUS HEPATITIS A TESTS |
MULTIPLE: IMX HAVAB; IMX HAVAB-M |
| 133 |
VARIOUS HIV ANTIBODY TESTS |
MULTIPLE PRODUCT NAMES |
| 134 |
VARIOUS HIV ANTIGEN TESTS |
MULTIPLE PRODUCT NAMES |
| 135 |
VARIOUS LH OR LUTEINIZING HORMONE ASSAYS |
MULTIPLE: ARCHITECT, AXSYM, IMXLH |
| 136 |
VARIOUS NAPA ASSAYS |
MULTIPLE; AXSYM NAPA; TDX/TDXFLX NAPA |
| 137 |
VARIOUS PROLACTIN ASSAYS |
MULTIPLE: IMX, AXSYM, & ARCHITECT PROLACTIN |
| 138 |
VARIOUS SALICYLATE ASSAYS |
MULTIPLE: AXSYM SLICYLATE ; TDX/TDXFLX/ADX SALICYLATE |
| 139 |
VARIOUS SECONDARY CALIBRATORS |
MULTIPLE PRODUCT NAMES |
| 140 |
VARIOUS SIZES |
DRAINAGE SET |
| 141 |
VARIOUS SIZES AND CONFIGURATIONS OF STERILE MONITORING KITS |
MONITORING KIT |
| 142 |
VARIOUS SIZES OF STERILE FILTERS (STERILE) |
MULTIPLE PRODUCT NAMES |
| 143 |
VARIOUS STAND ALONE BLOOD BANK SOFTWARE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 144 |
VARIOUS STERILE CONTAINERS |
MULTIPLE PRODUCT NAMES |
| 145 |
VARIOUS STERILE DRAPES |
MULTIPLE PRODUCT NAMES |
| 146 |
VARIOUS T4 OR THYROXINE ASSAYS |
MULTIPLE:IMX, AXSYM, ARCHITECT T4 |
| 147 |
VARIOUS TRICYCLIC ANTIDEPRESSANT ASSAYS |
MULTIPLE; AXSYM, TDX/TDX FLX/ADX TCA |
| 148 |
VARIOUS TYPES |
CVP CATHETER |
| 149 |
VARIOUS TYPES |
PRESSURE INFUSION CUFF |
| 150 |
VARIOUS TYPES |
CARPUJECT HOLDER |
| 151 |
VARIOUS TYPES |
MULTIPLE PRODUCT NAMES |
| 152 |
VARIOUS TYPES |
MULTIPLE PRODUCT NAMES |
| 153 |
VARIOUS TYPES |
MULTIPLE PRODUCT NAMES |
| 154 |
VARIOUS TYPES |
MULTIPLE PRODUCT NAMES |
| 155 |
VARIOUS TYPES ANGIOGRAPHIC SYRINGES |
MULTIPLE PRODUCT NAMES |
| 156 |
VARIOUS TYPES OF ARTERIAL PRESSURE TUBING |
ARTERIAL PRESSURE TUBING, EXTENSION SET |
| 157 |
VARIOUS TYPES OF CATHETER SETS (STERILE) |
MULTIPLE PRODUCT NAMES |
| 158 |
VARIOUS TYPES OF FLOW DIRECTED CATHETER |
MULTIPLE PRODUCT NAMES |
| 159 |
VARIOUS TYPES OF I.V. SETS W/STOPCOCKS |
MULTIPLE PRODUCT NAMES |
| 160 |
VARIOUS TYPES OF INFUSION PUMPS (NON-STERILE) |
MULTIPLE PRODUCT NAMES |
| 161 |
VARIOUS TYPES OF MONITORING KITS |
MULTIPLE PRODUCT NAMES |
| 162 |
VARIOUS TYPES OF SETS & ACCESSORIES (STERILE) |
MULTIPLE PRODUCT NAMES |
| 163 |
VARIOUS TYPES OF THERMODILUTION PROBES |
MULTIPLE PRODUCT NAMES |
| 164 |
VARIOUS TYPES OF TRANSFER AIDS |
MULTIPLE PRODUCT NAMES |
| 165 |
VARIOUS TYPES OF VENIPUNCTURE PROCEDURAL KITS W/SITE CARE DRESSING |
MULTIPLE PRODUCT NAMES |
| 166 |
VARIOUS URINE DRAINAGE SETS (STERILE) |
MULTIPLE URINE DRAINAGE SETS |
| 167 |
VARIOUS VALPROIC ACID |
MULTIPLE: AXSYM VALPROIC ACID; TDX/TDXFLX VALPROIC ACID |
| 168 |
VARIOUS VANCOMYCIN ASSAYS |
MULTIPLE AXSYM VANCOMYCIN; TDX/TDXFLX VANCOMYCIN |
| 169 |
VITAMIN B12 |
AXSYM B12 |
| 170 |
WINGED INFUSION SET (STERILE) |
BUTTERFLY |
| All FDA-Registered products for this company are displayed above. |