FDA Registration Active 🇺🇸 United States

ABBOTT LABORATORIES

Reg #: 3016438761 · FEI: 3016438761 · Expires 2026
Products
71
Proprietary Names
412
Establishment Types
2
Classifications
71

Registration Details

Registration Name
ABBOTT LABORATORIES
Registration Number
3016438761
FEI Number
3016438761
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1915 Hurd Drive
City
Irving
State
TX
ZIP
75038
Country
US

Regulatory Submissions

510(k) Number
K991010

Owner / Operator

Firm Name
ABBOTT LABORATORIES
Operator Number
1415939
Address
100 ABBOTT PARK RD., D-03Q3, AP52-1
City
Abbott Park
State
IL
Postal Code
60064
Country
US

Products

Device Name Product Code
Acid Phosphatase, Naphthyl Phosphate CKB
Enzymatic, Carbon-Dioxide KHS
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
System, Test, Human Chorionic Gonadotropin DHA
Igg, Antigen, Antiserum, Control DEW
Bromcresol Purple Dye-Binding, Albumin CJW
Slide Stainer, Automated KPA
Mixture, Control, White-Cell And Red-Cell Indices GLQ
Hexokinase, Glucose CFR
Detergent JCB
Turbidimetric, Total Protein JGQ
Photometric Method, Magnesium JGJ
Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
Calibrator, Multi-Analyte Mixture JIX
Diluent, Blood Cell GIF
Complement C4, Antigen, Antiserum, Control DBI
Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
Iga, Antigen, Antiserum, Control CZP
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
Electrode, Ion-Specific, Chloride CGZ
Electrode, Ion Specific, Sodium JGS
Electrode, Ion Specific, Potassium CEM
Calculator/Data Processing Module, For Clinical Use JQP
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
Azo Dye, Calcium CJY
Test, Equipment, Automated Bloodborne Pathogen MZA
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Alkaline Picrate, Colorimetry, Creatinine CGX
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
Calibrator, Secondary JIT
Diazo Colorimetry, Bilirubin CIG
Bilirubin (Total And Unbound) In The Neonate Test System MQM
Counter, Differential Cell GKZ
Ph Buffer JCC
Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
General Purpose Reagent PPM
Enzymatic Esterase--Oxidase, Cholesterol CHH
Romanowsky Stains GJL
Fixative, Alcohol Containing LDZ
Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
Prealbumin, Antigen, Antiserum, Control JZJ
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) JRS
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Assay, Glycosylated Hemoglobin LCP
Hemoglobin A1c Test System PDJ
Products, Red-Cell Lysing Products GGK
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
Calibrator For Cell Indices KRX
Calibrator For Platelet Counting KRY
Calibrator For Hemoglobin And Hematocrit Measurement KRZ
Calibrator For Red-Cell And White-Cell Counting KSA
Bromcresol Green Dye-Binding, Albumin CIX
Complement C3, Antigen, Antiserum, Control CZW
Transferrin, Antigen, Antiserum, Control DDG
Fluid, Diluting, White-Cell GGJ
Stain, Reticulocyte GJH
Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
Biuret (Colorimetric), Total Protein CEK
Haptoglobin, Antigen, Antiserum, Control DAD
Catalytic Methods, Amylase JFJ
System, Test, Rheumatoid Factor DHR
Acid, Uric, Uricase (Colorimetric) KNK
Slides, Microscope KEW
Alpha-1-Lipoprotein, Antigen, Antiserum, Control DER
Igm, Antigen, Antiserum, Control DFT

Proprietary Names

ACID PHOSPHATASE (ACP) (LN 9D87-21) CARBON DIOXIDE (LN 3L80-21, 3L80-31, 3L80-22, 3L80-32, 3L80-42) Alinity c Carbon Dioxide Reagent Kit (LN 07P7220, 07P7230) Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131) Alinity i System Accessories Alinity i System Alinity i Refurbished Processing Module (LN 03R65-84) Immunoglobulin G (IgG) (LN 9D99-21, 9D99-22) Aliniity c Immunoglobulin G Reagent Kit (LN 09P6220) Immunoglobulin G (IgG) (Alinity c, LN 09P6224) Immunoglobulin G (IgG) (ARCHITECT, LN 09D9924) ALBUMIN BCP (LN 7D54-21) Alinity c Albumin BCP Reagent Kit (LN 08P0320) Alinity h-series Slide Label Cartridge (LN 09P8201) Alinity h-series Smear Tape Cartridge (LN 09P8301) CELL-DYN 18 Plus Control (LN 07V07-06, 07V07-12) CELL-DYN 22 Plus Control (LN 07V09-06, 07V09-12) GLUCOSE (LN 3L82-21, 3L82-41, 3L82-22, 3L82-42) CELL-DYN Emerald Cleaner (LN 09H46-02) CELL-DYN Emerald 22 Easy Cleaner (LN 09H60-03) CELL-DYN Enzymatic Cleaner Concentrate (LN 99644-01) URINE/CSF PROTEIN (UPro) (LN 7D79-21, 7D79-31, 7D79-22, 7D79-32) Alinity c Urine/CSF Protein Reagent Kit (LN 07P5920, 07P5930) MAGNESIUM (LN 7D70-21, 7D70-31) ACTIVATED ASPARTATE AMINOTRANSFERASE (LN 8L91-21, 8L91-41) Urine/CSF Protein Calibrator (LN 1E71-02) Iron/Magnesium Calibrator (LN 1E69-03) Bilirubin Calibrator (LN 1E66-04) Lipase Calibrator (LN 3E16-02) Carbon Dioxide Calibrator (LN 1E64-02) CELL-DYN Diluent/Sheath (LN 01H73-01) CELL-DYN Emerald 22 Diluent (LN 09H62-01) CELL-DYN Emerald Diluent (LN 09H48-02) Alinity h-series Diluent (LN 04R2601) Complement C4 (LN 9D97-21, 9D97-22) Alinity c Complement C4 Reagent Kit (LN 09P5720) Complement C4 (Alinity c, LN 09P5724) Complement C4 (ARCHITECT, LN 09D9724) MULTICONSTITUENT CALIBRATOR (LN 1E65-05) TDM Multiconstituent Calibrator (LN 5P04-01) ASPARTATE AMINO TRANSFERASE (AST) (LN 7D81-21) Alinity c Phosphorus Reagent Kit (LN 08P4020, 08P4030) Phosphorus2 (Alinity c, LN 04U0320, 04U0330) Phosphorus2 (ARCHITECT, LN 04T0720, 04T0730) TRIGLYCERIDE (7D74-21, 7D74-22) Immunoglobulin A (IgA) (LN 9D98-21, 9D98-22) Specific Proteins Multiconstituent Calibrator (LN 1E78-02) Alinity c Immunoglobulin A Reagent Kit (LN 09P6120) Immunoglobulin A (IgA) (Alinity c, LN 09P6124) Immunoglobulin A (IgA) (ARCHITECT, LN 09D9824) LACTATE DEHYDROGENASE (LDH) (LN 2P56-21, 2P56-22, 2P56-42) Alinity c Lactate Dehydrogenase Reagent Kit (LN 07P7420, 07P7430) Lactate Dehydrogenase2 (LN 04T0320, 04T0330, 04T9920, 04T9930) Accelerator APS Alinity c Ultra HDL Reagent Kit (LN 07P7520, 07P7530) ULTRA HDL (LN 3K33-21, 3K33-22) Alinity c Calcium Reagent Kit (LN 07P5720, 07P5730) CALCIUM (LN 3L79-21, 3L79-31, 3L79-22, 3L79-32, 3L79-42) Alinity s System Accessories Alinity s System Magnesium (LN 3P68-22, 3P68-32) Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930) Magnesium (Alinity c; LN 08P1925, 08P1934) Magnesium (ARCHITECT; LN 03P6824, 03P6834) LIPID MULTICONSTITUENT CALIBRATOR (LN 5P56-01) CREATININE (LN 3L81-22, 3L81-32, 3L81-23, 3L81-33) Alinity c Creatinine Reagent Kit (LN 07P9920, 07P9930) Alinity c System CELL-DYN 29 Plus Control (w/Retics) (LN 08H58-01, 08H58-02) Alinity h-series Control 29P (LNs 04U7206, 04U7212, 06V87-06, 06V87-12) GAMMA-GLUTAMYL TRANSFERASE (GGT) (LN 7D65-21, 7D65-22, 7D65-42) Alinity c Gamma-Glutamyl Transferase Reagent Kit (LN 07P7320, 07P7330) Gamma-Glutamyl Transferase2 (ARCHITECT; LN 04T0020, 04T0030) Gamma-Glutamyl Transferase2 (Alinity c; LN 04T9620, 04T9630) Lipase2 Calibrator (LN 04U0001, 04T0401) LIPASE (LN 7D80-31) Lipase2 (LN 04T0420, 04U0020) Alinity ci-series System Control Module (LN 03R7001) Alinity c Processing Module (LN 03R6701) Alinity c System Accessories Alinity c Glucose Reagent Kit (LN 07P5520, 07P5530) ALKALINE PHOSPHATASE (LN 7D55-21, 7D55-22, 7D55-31, 7D55-32) Alinity c Alkaline Phosphatase Reagent Kit (LN 08P2020, 08P2030) DIRECT BILIRUBIN (LN 8G63-21, 8G63-22) Alinity c Direct Bilirubin Reagent Kit (LN 07P9720) ARCHITECT System Accessories ARCHITECT System Alinity c Aspartate Aminotransferase Reagent Kit (LN 08P1720) Alinity c Activated Apartate Aminotransferase Reagent Kit (LN 08P2320) Activated Aspartate Aminotransferase (LN 8L91-22, 8L91-42) Aspartate Aminotranserase (LN 7D81-22) Aspartate Aminotransferase2 (ARCHITECT; LN 04S9020, 04S9030) Activated Aspartate Aminotransferase (ARCHITECT, LN 08L9124, 08L9144) Activated Aspartate Aminotransferase (A-AST) (Alinity c, LN 08P2324) Aspartate Aminotransferase2 (Alinity c; LN 04T8620,04T8630) TOTAL BILIRUBIN (LN 6L45-21, 6L45-41, 6L45-22, 6L45-42) Alinity c Total Bilirubin Reagent Kit (LN 04V5121, 04V5131) Total Bilirubin (LN 7P32-21, 7P32-41) CELL-DYN EMERALD (LN 09H39-01) Alinity h-series Phosphate Buffer (LN 07P8301) ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22) ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42) Alinity c Alanine Aminotransferase Reagent Kit (LN 07P9820) Alinity c Activated Alanine Aminotransferase Reagent Kit (LN 08P1820) Alanine Aminotransferase2 (Alinity c; LN 04T8420, 04T8430) Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824) Alanine Aminotransferase2 (ARCHITECT; LN 04S8820, 04S8830) Activated Alanine Aminotransferase (ARCHITECT, LN 08L9224, 08L9244) Cystatin C Calibrators (LN 06T3201) Alinity i Syphilis TP Calibrator (LN 07P6001) Alinity i Progesterone Calibrators (LN 08P3601) Alinity i 25-OH Vitamin D Calibrators (LN 08P4501) Alinity i Total T4 Calibrators (LN 07P9501) Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801) Alinity i FSH Calibrators (LN 07P4901) Alinity i Free T4 Calibrators (LN 07P7001) Alinity i B12 Calibrators (LN 07P6702) Alinity c UIBC Calibrator Kit (LN 08P4401) Alinity i Prolactin Calibrators (LN 07P6601) Alinity i Total B-hCG Calibrators (LN 07P5101) Alinity i TSH Calibrators (LN 07P4801) Alinity c Hemoglobin A1c Calibrators (LN 08P4301) Alinity i C-Peptide Calibrators (LN 09P3601) Alinity i Ferritin Calibrators (LN 07P6501) Alinity i Intact PTH Calibrators (LN 08P3102) Alinity i Estradiol Calibrators (LN 07P5001) Lipase NG OC Calibrator (LN 04Y8501) Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601) Alinity i LH Calibrators (LN 07P9101) Alinity i Anti-TPO Calibrators (LN 09P3501) Alinity i T-Uptake Calibrators (LN 08P1201) Alinity i Folate Calibrators (LN 08P1402) Alinity c B2-Microglobulin Calibrator (LN 01R0902) Alinity i Insulin Calibrators (LN 04T7501) Alinity c Prealbumin Calibrator Kit (LN 04S0101) Alinity i CA 15-3 Calibrators (LN 08P5101) Alinity i Anti-Tg Calibrators (LN 09P3401) Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002) Alinity i Cortisol Calibrators (LN 08P3301) Alinity c Lp(a) Calibrators (LN 01R1401) Alinity i CA 125 II Calibrators (LN 08P4901) Alinity i DHEA-S Calibrators (LN 09P3701) Alinity i Homocysteine Calibrators (LN 09P2801) Alinity c ASO Calibrator (LN 01R0602) Alinity i Total T3 Calibrators (LN 07P9401) ARCHITECT Insulin Calibrators (LN 08K4103) Alinity i HE4 Calibrators (LN 08P5001) Alinity i CA 19-9XR Calibrators (LN 08P3201) ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01) ARCHITECT Total T3 Calibrators (LN 7K64-02) Alinity i Free T3 Calibrators (LN 07P6901) Alinity i Tacrolimus Calibrators (LN 09P4201) Prealbumin Calibrator (LN 6E57-03) Alinity i Sirolimus Calibrators (LN 09P4101) Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101) Acetaminophen Calibrator (LN 03R7401) Acetaminophen Calibrator (Alinity c, LN 07P5401) UCH-L1 Calibrators (Alinity i, LN 04W1901) GFAP Calibrators (ARCHITECT, LN 4W16-01) Alinity i BRAHMS PCT Calibrators (LN 01R1801) GFAP Calibrators (Alinity i, LN 04W1701) Alere NT-proBNP for Alinity i Calibrators (LN 04S7902) ACE Calibrator (LN 06U8601) UCH-L1 Calibrators (ARCHITECT, LN 4W18-01) ACE Calibrator (LN 06U8201) Alinity i CMV IgG Calibrators (LN 07P4202) DAPI I Counterstain (1000 ng/mL) 500 ?L x 2 Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL) Enzyme Conjugate Diluent 2.5X DF with Low Sodium Bisulfite GPR (600 mL) Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (40 mL) CGH Target Slides Higher pH Antibody Diluent DF 2X NAD and G6P GPR (100 mL) VP 2000 Pretreatment Reagent (500 mL) Lower pH Enzyme Conjugate Diluent DF GPR (600 mL) Enzyme Conjugate Diluent DF GPR (700 mL) Alcohol Diluent GPR 60 mL VYSIS Paraffin Pretreatment Reagent KIT Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (400 mL) Higher pH Antibody Diluent DF 2X NAD and G6P GPR (1000 mL) VP 2000 Protease I (250 mg x 2) NICK Translation Kit Abbott Proteinase K SpectrumGreen Male Reference DNA Paraffin Pretreatment Kit III Protease Buffer II Gold dUTP rTth Polymerase DNA Activation Reagent SpectrumRed Female Reference DNA CEP Hybridization Buffer VP 2000 Protease Buffer (500 mL) SpectrumGreen Female Reference DNA AMP Check E GPR Master Mix E GPR ProbeChek MultiVysion Control Slides Abbott Bisulfite Modification Kit Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 50mL) Vysis IntelliFish Universal FFPE Tissue Pretreatment and Wash Vysis IntelliFish Hybridization Buffer 1x250 uL Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 500mL) Vysis IntelliFish Hybridization Buffer 5x250 uL Abbott mSample Preparation System Bulk mLysis DNA Buffer Alinity h-series AutoClean Solution (LN 01R5104) DAPI II Counterstain (125 ng/mL) VP 2000 Reagents ? Protease II (750 mg) 750 mg Orange dUTP Aqua dUTP 20X SSC, 500g RNA AMP Check VYSIS PARAFFIN PRETREATMENT KIT I SpectrumRed Male Reference DNA CGH NICK Translation Reagent Set VP 2000 Reagents ? 2N MgCl 2 (120 mL) DAPI III Counterstain (42 ng/mL) 500 ?L x 2 LSI®/WCP® Hybridization Buffer Hemo-De Solvent CGH NICK TRANSLATION REAGENTSET DNA AMP Check CGH Hybridization Reagent Kit Assembly Human Cot-1 DNA, 250 uL For Laboratory Use RNA Activation Reagent SpectrumGreen CGH Control DNA (MPE 600) NP-40 1000µL x 2 Red dUTP Antibody Diluent DF 2X NAD and G6P GPR (1000 mL) Enzyme Conjugate Diluent DF GPR (70 mL) Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml) HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL) HEIA Enzyme Conjugate Diluent DF GPR (100 mL) Green dUTP LSI®/WCP® Hybridization Buffer 2 x 500 ?L, For Laboratory Use Lower pH Enzyme Conjugate Diluent DF GPR (60 mL) Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (60 mL) Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (100 mL) Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (1000 mL) Antifade II Solution 60 ?L x 2 Taq Gold Polymerases Pretreatment Reagent 500 mL Enzyme Conjugate Diluent DF GPR (600 mL) Propidium Iodide Counterstain CGH Control DNA (MPE 600) Unlabeled Enzyme Conjugate Diluent DF GPR (60 mL) Paraffin Pretreatment Kit II FISH Specimen Pretreatment Reagent Kit Antifade Solution, 2 x 240 µL For Laboratory Use Antifade II Solution, 2 x 60 uL, For Laboratory Use VP 2000 Reagents ? 20X SSC (500 g) Antibody Diluent DF 2X NAD and G6P GPR (100 mL) VYSIS FISH Specimen Pretreatment Reagent Kit Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL) CHOLESTEROL (LN 7D62-21, 7D62-22) Alinity c Cholesterol Reagent Kit (LN 07P7620) Alinity h-series May-Grunwald-Giemsa Stain (LN 08P8101) Alinity h-series Wright-Giemsa Stain (LN 08P8001) Alinity h-series Smear Fix (LN 08P7901) Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503) Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201) Alinity c Multiconstituent Calibrator Kit (LN 08P6001) Alinity c ICT Urine Calibrator Kit (LN 08P7001) ICT Urine Calibrator (LN 1E47-03) Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601) Alinity c ICT Serum Calibrator Kit (LN 08P6901) Alinity c Proteins Calibrators (LN 08P6702) ICT Serum Calibrator (LN 1E46-04) Alinity i Anti-CCP Calibrators (LN 09P2701) Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403) Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201) Alinity c Bilirubin Calibrator Kit (LN 08P6101) Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101) Alinity c Iron Calibrator Kit (LN 04U7501) Bilirubin Calibrator (LN 1E66-05) Urine/CSF Protein Calibrator (LN 1E71-03) Carbon Dioxide Calibrator (LN 1E64-03) Specific Proteins Multiconstituent Calibrator (LN 1E78-04) Multiconstituent Calibrator (LN 1E65-06) Lipid Multiconstituent Calibrator (LN 5P56-02) Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501) Consolidated Chemistry Calibrator (Alinity c; LN 04V6201) ICT (Sodium, Potassium, Chloride) Alinity c Apolipoprotein B Reagent Kit (LN 09P4720) Apolipoprotein B (Alinity c, LN 09P4724) Apolipoprotein B (ARCHITECT, LN 09D9324) APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22) PREALBUMIN (LN 1E02-21, 1E02-22, 01E0224) Prealbumin Calibrator (LN 6E57-02) Alinity c Prealbumin Reagent Kit (LN 09P8620) Prealbumin (Alinity c, LN 09P8624) Alinity h-series Water Purification System (LN 09P7101) Hemoglobin A1c (LN 4P52-20, 4P52-22) Hemoglobin A1c Controls (LN 4P52-11) Hemoglobin A1c Calibrators (LN 4P52-01) Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321) CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02) CELL-DYN CN-Free HGB Reagent (LN 01H79-01) CELL-DYN CN Free HGB/NOC Lyse (LN 03H80-02) CELL-DYN WBC Lyse (LN 08H52-01) CELL-DYN Emerald CN-Free Lyse (LN 09H47-02) CELL-DYN Emerald 22 Lyse (LN 09H6101) Alinity h-series HGB Reagent (LN 07P8104) CELL-DYN WBC Reagent - Part A (LN 01H77-01/01H77-02) CREATINE KINASE (LN 7D63-21, 7D63-22, 7D63-42) Alinity c Creatine Kinase Reagent Kit (LN 08P4220) PHOSPHOURUS (PHOS) (LN 7D71-22, 7D71-31, 7D71-23, 7D71-32) Alinity hs (09P69-02) ALINITY HS SLIDE MAKER STAINER MODULE (09P69-01) ALINITY HQ ANALYZER (09P68-01) Alinity hq (LN 09P68-02) CELL-DYN HemCal Plus (LN 08H57-01) Alinity h-series HemCal (LN 04U7302, 06V86-02) ALBUMIN BCG (ALBG) (LN 7D53-23, 7D53-24) Alinity c Albumin BCG Reagent Kit (LN 08P0220) Complement C3 (LN 9D96-21, 9D96-22) Alinity c Complement C3 Reagent Kit (LN 09P5620) Complement C3 (ARCHITECT, LN 09D9624) Complement C3 (Alinity c, LN 09P5624) Alinity c ICT Sample Diluent (LN 07P5320) Transferrin (LN 1E04-21, 1E04-22, 1E04-42) Alinity c Transferrin Reagent Kit (LN 08P3820) Transferrin (Alinity c, LN 08P3824) Transferrin (ARCHITECT, LN 01E0424 and 01E0444) Alinity h-series WBC Reagent (LN 07P7904) Alinity hq Processing Module (LN 09P6801) Alinity hs Processing Module (LN 09P6901) CELL-DYN Sapphire System Reticulocyte Reagent (LN 01H76-01) Alinity h-series Retic Reagent (LN 07P8004) CELL-DYN Reticulocyte Reagent (LN 03H40-01) Emerald 22 Autoloader Analyzer (LN 04R1301) UREA NITROGEN (LN 7D75-21, 7D75-31, 7D75-22, 7D75-32) Alinity c Urea Nitrogen Reagent Kit (LN 08P1620, 08P1630) ACE Control (LN 06U8210) Cystatin C Controls (LN 06T3210) Alinity i Total B-HCG Controls (LN 07P5110) Alinity i Estradiol Controls (LN 07P5010) FreeStyle Control Solution Alinity i Total T4 Controls (LN 07P9510) Alinity i 2nd Generation Testosterone Controls (LN 07P6810) Alinity i Intact PTH Controls (LN 08P3111) Alinity i Prolactin Controls (LN 07P6610) Alinity i Free T4 Controls (LN 7P7010) Alinity i TSH Controls (LN 07P4810) Alinity i Insulin Controls (LN 04T7510) Alinity i FSH Controls (LN 07P4910) Alinity i HE4 Controls (LN 08P5010) Lipase NG OC Control 2 (LN 04Y8511) Alinity i Progesterone Controls (LN 08P3610) Alinity i Syphilis TP Controls (LN 07P6010) Alinity i 25-OH Vitamin D Controls (LN 08P4512) Alinity i CA 125 II Controls (LN 08P4910) Alinity c ASO Control I (LN 04S0912) Alinity c Ammonia Controls (LN 08P2210) Alinity i CA 15-3 Controls (LN 08P5110) ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10) Alinity i CA 19-9XR Controls (LN 08P3210) Lipase NG OC Control 1 (LN 04Y8510) Alinity i Ferritin Controls (LN 07P6510) Alinity c Lp(a) Control Kit (LN 01R1410) Alinity i Homocysteine Controls (LN 09P2810) Alinity i C-Peptide Controls (LN 09P3610) Alinity i Folate Controls (LN 08P1412) Alinity i B12 Controls (LN 07P6712) Alinity i Anti-Tg Controls (LN 09P3410) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610) Alinity c ASO Control II (LN 04S0913) Alinity i DHEA-S Controls (LN 09P3710) Alinity c Hemoglobin A1c Controls (LN 08P4310) Alinity i Anti-TPO Controls (LN 09P3510) Alinity c Cannabinoids Control 2 Kit (LN 09P5411) Alinity c Cannabinoids Control 1 Kit (LN 09P5410) Alinity i T-Uptake Controls (LN 08P1210) ARCHITECT Insulin Controls (LN 08K4112) Alinity i Free T3 Controls (LN 07P6910) MediSense Control Solution Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110) GFAP Controls (Alinity i, LN 04W1710) UCH-L1 Controls (Alinity i, LN 04W1910) GFAP Controls (ARCHITECT, LN 4W16-10) Alinity i BRAHMS PCT Controls (LN 01R1810) Alere NT-proBNP for Alinity i Controls (LN 04S7911) Alinity i CMV IgG Controls (LN 07P4212) ACE Control (LN 06U8610) UCH-L1 Controls (ARCHITECT, LN 4W18-10) TOTAL PROTEIN (LN 7D73-21, 7D73-22) Alinity c Total Protein Reagent Kit (LN 07P5220) Total Protein2 (ARCHITECT; LN 04U4420, 04U4430) Total Protein2 (Alinity c; LN 04T8120, 04T8130) Haptoglobin (LN 9D91-21) Alinity c Haptoglobin Reagent Kit (LN 09P5920) Haptoglobin (Alinity c, LN 09P5924) Haptoglobin (ARCHITECT, LN 09D9124) CELL-DYN 18 Plus Calibrator (LN 07V06-02) CELL-DYN 22 Plus Calibrator (LN 07V11-02) CELL-DYN Emerald 22 (LN 09H5901) Alinity c Amylase Reagent Kit (LN 07P5820) AMYLASE (LN 7D58-21 and 7D58-22) Alinity c Rheumatoid Factor Reagent Kit (LN 04R9921) Rheumatoid Factor Calibrator (LN 8G67-02) Rheumatoid Factor (Alinity c, LN 04R9924) RHEUMATOID FACTOR (RF) (LN 8G66-21) Rheumatoid Factor (ARCHITECT, LN 08G6624) URIC ACID (LN 3P39-21) Alinity h-series Glass Slides (LN 09P8420) APOLIPOPROTEIN A1 (ApoA) (LN 9D92-21, 9D92-22) Alinity c Apolipoprotein A1 Reagent Kit (LN 09P4620) Apolipoprotein A1 (Alinity c, LN 09P4624) Apolipoprotein A1 (ARCHITECT, LN 09D9224) Immunoglobulin M (IgM) (LN 1E01-21, 1E01-22) Alinity c Immunoglobulin M Reagent Kit (LN 09P6320) Immunoglobulin M (IgM) (Alinity c, LN 09P6324) Immunoglobulin M (IgM) (ARCHITECT, LN 01E0124) Alinity c Uric Acid Reagent Kit (LN 08P5620, 08P5630) Uric Acid (LN 3P39-22, 3P39-42) Uric Acid2 (Alinity c; LN 04U0920, 04U0930)

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device