FDA Registration Active 🇺🇸 United States

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Reg #: 2517506 · FEI: 2517506 · Expires 2026
Products
160
Proprietary Names
726
Establishment Types
5
Classifications
160

Registration Details

Registration Name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Registration Number
2517506
FEI Number
2517506
Status
Active
Expiry Year
2026
Initial Importer
No
Address
500 GBC DR, PO Box 6101
City
NEWARK
State
DE
ZIP
19714
Country
US

Regulatory Submissions

510(k) Number
K060264
PMA Number
P020027

Owner / Operator

Firm Name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Operator Number
9096044
Address
Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
City
Tarrytown
State
NY
Postal Code
10591
Country
US

Products

Device Name Product Code
Photometric Method, Iron (Non-Heme) JIY
Enzyme Immunoassay, Diphenylhydantoin DIP
Myoglobin, Antigen, Antiserum, Control DDR
Immunoassay Method, Troponin Subunit MMI
Calibrator, Secondary JIT
Fluorometric Method, Cpk Or Isoenzymes JHX
Fluorescent Immunoassay, Tobramycin LCR
Calibrators, Drug Mixture DKB
Enzyme Immunoassay, N-Acetylprocainamide LAN
Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
Enzyme Immunoassay, Procainamide LAR
Drug Mixture Control Materials DIF
Radioimmunoassay, Free Thyroxine CEC
Radioimmunoassay, Thyroid-Stimulating Hormone JLW
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
Alkaline Picrate, Colorimetry, Creatinine CGX
Enzymatic, Carbon-Dioxide KHS
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Calibrators, Drug Specific DLJ
Enzyme Immunoassay, Opiates DJG
Drug Specific Control Materials LAS
Radioassay, Vitamin B12 CDD
Calibrator, Multi-Analyte Mixture JIX
Enzyme Immunoassay, Carbamazepine KLT
Liquid Chromatography, Amphetamine DNI
Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
Enzyme Immunoassay, Phencyclidine LCM
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
Radioimmunoassay, Methaqualone KXS
Enzymatic Method, Creatinine JFY
Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
Ferrozine (Colorimetric) Iron Binding Capacity JMO
Electrode, Ion-Specific, Chloride CGZ
Bromcresol Purple Dye-Binding, Albumin CJW
Electrode, Ion Specific, Sodium JGS
Electrode, Ion Specific, Potassium CEM
Radioimmunoassay, Barbiturate DKN
Enzyme Immunoassay, Methadone DJR
Enzyme Immunoassay, Amphetamine DKZ
High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs LFI
High Pressure Liquid Chromatography, Methamphetamine LAG
Enzyme Immunoassay, Barbiturate DIS
Reagents, Test, Tetrahydrocannabinol DKE
Enzyme Immunoassay, Digoxin KXT
Enzyme Immunoassay, Phenobarbital DLZ
Complement C3, Antigen, Antiserum, Control CZW
Radioassay, Triiodothyronine Uptake KHQ
Complement C4, Antigen, Antiserum, Control DBI
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
Acid, Folic, Radioimmunoassay CGN
Diazo Colorimetry, Bilirubin CIG
Enzyme Immunoassay, Methotrexate LAO
Colorimetry, Salicylate DKJ
Enzyme Immunoassay, Valproic Acid LEG
Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
Radioimmunoassay, Tobramycin KLB
Enzymatic Radiochemical Assay, Tobramycin LDO
Enzyme Immunoassay, Quinidine LBZ
Mycophenolic Acid Test System OAV
Biuret (Colorimetric), Total Protein CEK
Ph Rate Measurement, Carbon-Dioxide JFL
Radioimmunoassay, Luteinizing Hormone CEP
Enzyme Immunoassay, Benzodiazepine JXM
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
System, Test, Human Chorionic Gonadotropin DHA
Enzyme Immunoassay, Tracrolimus MLM
Enzymatic Method, Bilirubin JFM
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
Colorimetric Method, Cpk Or Isoenzymes JHY
Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
Radioimmunoassay, Follicle-Stimulating Hormone CGJ
Radioimmunoassay, Immunoglobulins (G, A, M) CFQ
Multi-Analyte Controls, All Kinds (Assayed) JJY
Radioimmunoassay, Prolactin (Lactogen) CFT
Test, Natriuretic Peptide NBC
Radioimmunoassay, Amikacin KLQ
Colorimetry, Acetaminophen LDP
Calibrator, Primary JIS
Kit, Test,Alpha-Fetoprotein For Testicular Cancer LOJ
Enzyme Immunoassay, Theophylline KLS
Enzyme Immunoassay, Lidocaine KLR
Colorimetric Method, Lipoproteins JHM
Enzyme Immunoassay, Digitoxin LFM
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG
Radioimmunoassay, Vancomycin LEH
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions MTG
Enzyme Immunoassay, Gentamicin LCD
Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
Acid, Lactic, Enzymatic Method KHP
Analyzer, Chemistry, Micro, For Clinical Use JJF
Radioimmunoassay, Total Triiodothyronine CDP
System, Test, Vitamin D MRG
Acid, Uric, Uricase (Colorimetric) KNK
Differential Rate Kinetic Method, Cpk Or Isoenzymes JHS
Enzymatic Esterase--Oxidase, Cholesterol CHH
Photometric Method, Magnesium JGJ
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
System, Test, Low Density, Lipoprotein MRR
Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
Colorimetry, Cholinesterase DIH
Hexokinase, Glucose CFR
Catalytic Methods, Amylase JFJ
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
Prealbumin, Fitc, Antigen, Antiserum, Control DDS
System, Test, Carcinoembryonic Antigen DHX
Enzyme Immunoassay, Primidone DJD
Enzyme Immunoassay, Propoxyphene JXN
Enzyme Immunoassay, Cannabinoids LDJ
Sirolimus Test System NRP
Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
Test Reagents For Ethyl Alcohol DMJ
Enzymatic Method, Ammonia JIF
Acid Phosphatase, Thymolphthale Inmonophosphate CKE
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
Acid, Uric, Uricase (Oxygen Rate) JHC
Flame Photometry, Lithium JIH
System, Test, C-Reactive Protein DCN
Cyclosporine MKW
Assay, Glycosylated Hemoglobin LCP
Albumin, Antigen, Antiserum, Control DCF
Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
Chromatographic Separation, Cpk Isoenzymes JHT
Cresolphthalein Complexone, Calcium CIC
Transferrin, Antigen, Antiserum, Control DDG
Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
Radioimmunoassay, Immunoglobulins (D, E) JHR
System, Test, Radioallergosorbent (Rast) Immunological DHB
Bilirubin (Total And Unbound) In The Neonate Test System MQM
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes CJO
Fluorometer, For Clinical Use KHO
Everolimus Immunoassay OUF
Calculator/Data Processing Module, For Clinical Use JQP
Gas Chromatography, Methamphetamine LAF
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method DML
Ferritin, Antigen, Antiserum, Control DBF
Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
Calibrator, Surrogate JIW
Hemoglobin A1c Test System PDJ
Prealbumin, Antigen, Antiserum, Control JZJ
Radioimmunoassay, Lsd (125-I) DLB
Enzyme Immunoassay, Inhibin-A NDR
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
Assay, Porphyrin, Spectrophotometry, Lithium NDW
U.V. Spectrometry, Tricyclic Antidepressant Drugs LFH
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Fibrin Split Products GHH
Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
Radioimmunoassay, Parathyroid Hormone CEW
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase DLI
System, Test, Immunological, Antigen, Tumor MOI
Enzyme Immunoassay, Ethosuximide DLF
Haptoglobin, Antigen, Antiserum, Control DAD
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
Procalcitonin Assay PRI
Antistreptolysin - Titer/Streptolysin O Reagent GTQ
Radioimmunoassay, Progesterone JLS

Proprietary Names

Dimension IRON Flex Emit 2000 Phenytoin Assay Stratus CS Acute Care MYO TestPak Stratus CS Acute Care CKMB TestPak Stratus CS Acute Care CTNI CalPak Stratus CS Acute Care CKMB CalPak Stratus CS Acute Care CTNI TestPak Stratus CS Acute Care MYO CalPak Dimension TOBR Flex Atellica CH Tobramycin (Tob) Emit Ethyl Alcohol Cal Emit Ethyl Alcohol Negative Cal Emit Ethyl Alcohol Low Control Emit Ethyl Alcohol High Control Emit 2000 N-Acetylprocainamide Assay Emit tox Serum Tricyc Antidep Cal Emit tox Serum Tricyc Antidep Assay Emit 2000 Procainamide Assay Dimension Drugs of Abuse Pos Ctrl ADVIA® Chemistry Toxicology Controls Dimension Drugs of Abuse Neg Ctrl Dimension LOCI Free Thyroxine Flex reagent cartridge (LOCI FT4L) Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (LOCI TSHL) Dimension Vista CO2 Flex Dimension EXL 200 integrated chemistry system Dimension EXL with LM and STM Ready Dimension EXL with LM integrated chemistry system Dimension Vista Progesterone Calibrator Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2, Level 3, Level 4 Emit II Plus Specialty Drug Control Negative Emit II Plus Specialty Drug Control Positive Emit Cal/Controls Levels 0-5 Dimension LOCI Anemia Calibrator Dimension LOCI Vitamin B12 Flex Emit II Plus Barbiturate Assay Syva RapidTest d.a.u. 5 mAMP/OPI/COC/THC/PCP Emit II Plus Ethyl Alcohol Assay Emit II Plus Methaqualone Assay Atellica CH Enzymatic Creatinine_2 (ECre_2) Emit 2000 Carbamazepine Assay Dimension/Dimension Vista Enzyme Diluent Dimension Vista ALB Flex Dimension Vista CRBM Flex Dimension Vista TIBC Flex Dimension Vista AST Flex Atellica CH IMT Standard A (IMT Standard A) Atellica CH Reagent Probe Cleaner 1 (RPC1) Atellica CH 930 Analyzer Atellica CH Cleaner Atellica CH EMPTY Atellica CH Reagent Probe Cleaner 4 (RPC4) Atellica CH Lamp Coolant (LC) Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge) Atellica CH Water Bath Additive (WBA) Atellica CH IMT Diluent (IMT Diluent) Atellica Direct Load Atellica CH Reagent Probe Cleaner 2 (RPC2) Atellica CH Diluent Atellica CH IMT Dilution Check (IMT Dilution Check) Atellica CH Check Reagent (CHK) Atellica CH Albumin BCP Calibrator (AlbP CAL) Atellica CH Wash Atellica CH Conditioner Atellica CH EMPTY1 Atellica CH HA1c_E High Volume Labels (50) Atellica CH EMPTY2 Atellica CH HA1c_E High Volume Bottles (5) Atellica CH HA1c_E High Volume Conversion Kit Atellica CH Lid Keying Feature Atellica CH 930 Analyzer (Fully Refurbished) Syva RapidTest d.a.u. 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP Vista DIGXN Flex Emit 2000 Phenobarbital Assay Dimension C3 Flex Dimension Vista TU Flex MAGIC LITE T UPTAKE REFERENCE SERUM Dimension C4 Flex ADVIA Chemistry Albumin BCP (ALBP) ADVIA Chemistry Albumin BCP CAL (ALBP CAL) Atellica CH Digoxin (Dgn) Stratus CS Acute Care DDMR CalPak Stratus CS Acute Care DDMR TestPak Dimension Vista FOL Flex Dimension Vista MYO Cal Dimension Vista MYO Flex Vista ENZ 6 Cal Atellica CH Diazo Direct Bilirubin (D_DBil) Syva Emit Methotrexate Assay Dimension SAL Flex Emit 2000 Valproic Acid Assay Dimension Vista Testosterone Calibrator Dimension Vista Total Testosterone Flex reagent cartridge Atellica CH Carbon Dioxide, Concentrated (CO2_c) ADVIA ADVIA Chemistry Emit 2000 Tobramycin Calibrators Emit 2000 Tobramycin Assay Emit 2000 Quinidine Assay Syva Emit 2000 Mycophenolic Acid Assay Dimension MPAT Flex Atellica CH Mycophenolic Acid (MPA) Dimension MPAT Cal Dimension MPAT Flex (DF215) Dimension FT4 Flex SCS MYO CalPak SCS MYO TestPak Atellica CH DRUG CAL (DRUG CAL) Dimension Drug Cal Dimension UCFP Flex Dimension FERR Cal QuikLyte IMT Flush Solution QuikLyte IMT Diluent Check QuikLyte IMT Sample Diluent Dimension BARB Flex Vista LH Flex MAGIC LITE LH LUTEN Emit II Plus Benzodiazepine Assays Atellica CH Benzodiazepines (Bnz) Atellica CH Benzodiazepines (BnzC) Stratus CS DDMR TestPak Dimension CCRP Flex Dimension MMB Cal Stratus CS BHCG TestPak Stratus CS BHCG CalPak Emit 2000 Tacrolimus Sample Pretrea Atellica CH Tacrolimus Emit 2000 Tacrolimus Assay Atellica CH Direct Bilirubin 2 (DBil_2) ADVIA Chemistry DBIL_2 IMMULITE 2000 T4 (TT4) Dimension T4 Flex Dimension Vista® CHK Flex® reagent cartridge Dimension Vista® Urea Nitrogen Flex® reagent cartridge V-Lyte Standard B Dimension Vista® Phenobarbital Flex® reagent cartridge Dimension Vista® Empty Flex® reagent cartridge Dimension Vista® Sample Probe Cleaner Dimension Vista® Cuvette Wash Solution Dimension Vista® Mass CKMB Isoenzyme Calibrator Dimension Vista® Small Sample Container (SSC) Dimension Vista® Reagent Probe Cleaner Dimension Vista® Aliquot Plates V-Lyte Dilution Check Dimension Vista® Barcode Labels V-Lyte Standard A V-Lyte Diluent V-Lyte Integrated Multisensor Dimension Vista® System Diluent Dimension Vista® Cuvettes Dimension Vista® Sample Cups Dimension Vista® Empty Vials Kit Dimension Vista® System (500, 1000T, 3000T) Dimension Vista® LOCI Reaction Vessels Dimension COC Flex Dimension LNTP Flex Dimension NTP Flex Emit Amikacin Assay Dimension OPI Flex Dimension ACTMN Flex Syva Emit 2000 Mycophenolic Acid Calibrators Syva RapidTest d.a.u. MDN Emit II Plus Phencyclidine Assay Dimension CCRP Cal Stratus CS Acute Care CCRP CalPak Dimension Vista AFP Flex Dimension Vista UDAT CON (Pos) Dimension Vista UDAT Con (Neg) Emit 2000 Procainamide Cals Atellica CH Theophylline (Theo) Dimension THEO Flex Emit II Plus Opiate Assays Atellica CH Opiates (Op) Atellica CH Opiates (OpC) Dimension LIDO Flex Atellica CH LIDO Assay Dimension Vista HDLC Flex Emit 2000 Digoxin Assay Emit II Plus Oxycodone Positive Control 300 Emit II Plus Oxycodone Negative Control 100 Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 Emit II Plus Oxycodone Negative Control 300 Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 Emit II Plus Oxycodone Positive Control 100 Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 Dimension DGTX Flex Dimension LOCI N-Terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge Dimension Vista LOCI B-type Natriuretic Peptide Flex reagent cartridge ADVIA Centaur NT-proBNP (PBNP) Atellica IM NT-proBNP (PBNP) Dimension Vista LOCI 7 Calibrator Dimension Vista LOCI CA 19-9 Flex VITROS Chemistry Products CAFFN Reagent Kit BOX/200T ADVIA Chemistry Cystatin C_2 Calibrator Atellica CH Cystatin C Calibrators (CysC CAL) Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL) Dimension Vista Chemistry 1 Calibrator Atellica CH Toxicology Calibrator (TOX CAL) Dimension Vista Thyroxine/Thyronine-Uptake Calibrator Atellica CH Special Chem CAL (SPCL CHEM CAL) Atellica CH Liquid Specific Protein Calibrators (LSP CAL) Atellica CH Protein 2 Calibrator (PROT2 CAL) Dimension VANC Flex Vista LOCI 8 Calibrator Atellica CH Ecstasy (XtcC) Emit II Plus Ecstasy Assay Atellica CH Ecstasy (Xtc) Dimension T/F PSA Cal Vista FPSA Flex Dimension FPSA Flex Emit Caffeine Assay Emit 2000 Quinidine Cals Atellica CH Iron3 (Iron_3) Dimension TP/ALB Cal Emit 2000 Gentamicin Plus Cals Emit 2000 Gentamicin Plus Assay Syva RapidTest d.a.u. BZO Dimension® Phosphorus Flex® reagent cartridge Emit Cal B Level 1 (cutoff) Emit Cal B Level 2 (high) Vista LA Flex Atellica CH Lac_3 EDMS Software System Dimension CRBM Flex Atellica CH Carbamazepine (Carb) Dimension FT3 Flex MAGIC LITE T3 100 TEST KIT IMMULITE 2000 Total T3 (T3) Dimension Vista FT3 Flex Dimension LOCI VITD Cal Dimension LOCI Vitamin D Total Assay Atellica CH A-LYTE IMT Cleaner Dimension Vista® Acid Clean Flex® reagent cartridge Emit Caffeine Control Dimension Vista BHCG Cal Dimension Vista BHCG Flex Dimension PHNO Flex Atellica CH Phenobarbital (Phnb) Emit 2000 Tacrolimus Cal Dimension Vista PCHE Flex Dimension Vista URCA Flex Dimension Vista PROC Flex Dimension Vista SAL Flex Dimension Vista TRIG Flex Dimension Vista TOBR Flex Dimension Vista PHOS Flex Dimension Vista GGT Flex Dimension Vista CHOL Flex Dimension Vista AMY Flex Dimension Vista T4 Flex Dimension Vista VALP Flex Dimension Vista ACTM Flex Dimension Vista GLU Flex Dimension Vista LDLC Flex Dimension Vista LIDO Flex Dimension Vista VANC Flex Dimension SAL Cal Dimension Everolimus Calibrator Dimension UCFP Cal Ictotest Dimension TGL Flex Atellica CH Triglyceride_2 (Trig_2) Dimension PALB Flex Dimension Vista CEA Flex Emit Primidone Assay Emit II Plus Buprenorphine Assay Emit II Plus Propoxyphene Assay Syva Emit II Plus 6-Acetylmorphine Cals/Controls Level 1-4 Syva Emit II Plus 6-Acetylmorphine Assay VITROS Chemistry Products Calibrator Kit 11 box/1 set/6 btls Syva RapidTest d.a.u. 3 THC/COC/OPI Dimension THY Cal Dimension SIRO Cal Dimension SIRO Flex Aptio Automation System Dimension Empty Flex Dimension Small Sample Container Dimension ALDL Flex Dimension TP Flex Dimension Vista A1AT Flex Atellica CH Alpha-1-Antitrypsin 2 (AAT2) Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) Atellica CH DRUG CAL II Syva RapidTest d.a.u. COC Dimension Vista THEO Flex Dimension Vista DGTX Flex Dimension Vista PTN Flex Dimension Vista GENT Flex Dimension ECO2 Flex Dimension Vista LOCI 1 Cal Dimension IGG Flex Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Atellica Rack Handler Atellica CI Reaction Cuvette Segments Atellica CI Dilution Cuvette Segments Atellica CI Analyzer; (Model 1900) Atellica CH Albumin BCP (AlbP) Atellica Direct Connect for CI VITROS Chemistry Products CAL KIT 26 IMMULITE 2000 Phenobarbital (PHE) IMMULITE 2000 Systems Diluent Tube Caps IMMUUTE 2000 Systems Microsampling Tubes IMMULITE 2000 Systems Allergen Tube Septum IMMULITE 2000 Systems Reaction Tubes IMMULITE 2000 Systems Diluent Tubes IMMULITE 2000 XPi System Sample Cup Nesting IMMULITE 2000 Chemiluminescent Substrate Module IMMULITE 2000 Systems Allergen Tube Caps IMMULITE 2000 Systems Microsampling Tube Caps IMMULITE 2000 XPi Immunoassay System IMMULITE 2000 Immunoassay System Emit Cal Level 0 (Neg) Dimension AMM Flex Atellica CH Ammonia (Amm) ADVIA Chemistry Total Bilirubin_2 (TBIL_2) Atellica CH Total Bilirubin_2 (TBIL_2) Clinitek Novus Pro 12 Atellica Japan Enzymatic Creatinine (ECreJ) Pack Dimension THC Flex Emit 2000 Cyclosporine Specific Asy Emit tox Serum Calibrators (Negative, Low, and Medium) Dimension Vista Lipase Flex ADVIA Chemistry Lipase Dimension Lipase Flex Atellica CH Protein 1 Calibrator (PROT1 CAL) Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL) Atellica CH Bilirubin Calibrator (BILI CAL) Emit 2000 Phenobarbital Cals Dimension FOL Flex Dimension B12 Flex Atellica IM NT proBNPII (PBNPII) ADVIA Centaur NT proBNPII (PBNPII) Dimension ENZ 1 Cal Dimension HCG Flex Dimension LHCG Flex Dimension Vista DBIL Flex Atellica CH Barbiturates (BrbC) Atellica CH Brb SCS Rotors SCS Cannula (BD) SCS Cannula (Sarstedt) SCS Printer Paper SCS Sample Cup SCS Pipette Tips SCS Cannula (Terumo) Stratus CS Analyzer SCS Waste Bin Liner ADVIA Chemistry ALP_2 Calibrator Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL) Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) Dimension ALPI Calibrator Dimension ALPI Flex Emit 2000 Theophylline Cals Emit 2000 Theophylline Assay Dimension Vista ENZ 1 Cal Dimension PALB Cal Stratus CS Acute Care CCRP TestPak Emi II Plus Methadone Assays Atellica CH Methadone (Mdn) Atellica CH Methadone (MdnC) Vista Enzyme 2 Calibrator Atellica CH Cannabinoids THC (ThcC) Emit II Plus Cannabinoid Assays Atellica CH Cannabinoids THC (Thc) Dimension Vista TIBC Cal Dimension PCHE Verifier Atellica CH Alanine Aminotransferase (ALT) Dimension Vista ALTI Flex Dimension ALTI Flex Atellica CH Alanine Aminotransferase P5P (ALTPLc) SCS CKMB DilPak Emit 2000 Cyclosporine Neg Cal Emit 2000 Cyclosporine Specific Cal Emit 2000 CSA Sample Pretreat Rgt Dimension CTNI Cal Atellica CH Oxycodone (OXYC) Emit II Plus Oxycodone Assay Atellica CH Oxycodone Assay Dimension Vista Oxycodone (OXY) Flex Reagent Cartridge Dimension Oxycodone (OXY) Flex Reagent Cartridge Dimension Vista CHEM 4 Cal Atellica CH HDL Cholesterol (HDLC) Atellica CH LDL Cholesterol (LDLC) Dimension PROC Flex Atellica CH Procainamide (PROC) Emit 2000 Phenytoin Cals Atellica CH Lactate Dehydrogenase L-P (LDLP) Dimension LDI Flex DM Vista LDI ADVIA Chemistry LDLP ADVIA Chemistry LDPL ADVIA Chemistry LAC Dimension Vista Creatinine Flex Reagent Cartridge (CRE2) Vista DGTX Cal Emit 2000 Vancomycin Assay Dimension EXTC Flex Emit tox Acetaminophen Calibrators Emit tox Acetaminophen Assay Advia Centaur with StreamLAB Dimension MBI Flex Dimension CKI Flex Dimension CKI-MBI Cal Dimension Everolimus Assay POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite Stratus CS D-Dimer TestPak DDMRE Emit II Plus Methadone Assay Syva RapidTest d.a.u. mAMP Emit II Plus Amphetamines Assay Dimension IGM Flex Emit II Plus Ethyl Alcohol Assays Atellica CH Gamma-Glutamyl Transferase_2 (GGT_2) Dimension IRON Cal Dimension Enzyme II Cal ADVIA Chemistry Salicylate (SAL) Atellica CH Salicylate (Sal) Atellica CH Salicylate (SalC) Dimension LOCI Thyroid Cal Dimension PTN Flex Atellica CH Phenytoin (Phny) Atellica CH Diazo Total Bilirubin (D_TBil) Atellica® CH N-acetylprocainamide (NAPA) Dimension NAPA Flex Dimension LI Flex Emit 2000 Carbamazepine Cals Dimension LOCI B-type Natriuretic Peptide Calibrator Dimension Vista LOCI B-type Natriuretic Peptide Calibrator Dimension CSA Flex Dimension MALB Flex Dimension MALB Cal Dimension Vista TBIL Flex Syva RapidTest d.a.u. THC Dimension Vista FERR Flex Vista FSH Flex IMMULITE® 2000 FSH IMMULITE® 2000 FSH Sample Diluent IMMULITE® / IMMULITE® 1000 FSH Dimension IBCT Flex Dimension TRNF Flex Dimension TBI/DBI Cal Dimension TBI Flex Dimension DBI Flex Dimension HCG Cal Atellica CH A1c_EZ PRE Atellica CH Enzymatic Hemoglobin A1c (A1c_E) ADVIA Chemistry A1c_E Reagent (4x300 Kit) ADVIA Chemistry A1c_E Pretreatment Buffer Kit ADVIA Chemistry A1c_E Reagent (2x150 Kit) Syva RapidTest d.a.u AMP Emit tox Serum Benzodiazepine Assay QuikLYTE IMT Std A QuikLyte IMT Std B Dimension Sample Cups with Lids Dimension CA Flex Dimension BUN Flex Dimension CHEM I Cal Purified Water Diluent Dimension Enzyme Verifier Dimension Cuvette Cartridge Dimension Salt Bridge Solution Syva RapidTest d.a.u. OPI Emit II Plus Opiate Assay Dimension Vista PREALB Flex N Antiserum to Human Prealbumin Atellica CH Prealbumin (PALB) Emit II Plus Cocaine Metabolite Assay ADVIA Chemistry Enzyme 2 Calibrator (ENZ 2 CAL) ADVIA Chemistry Enzyme 1 Calibrator (ENZ 1 CAL) Atellica CH ENZ 1 Calibrator (ENZ 1 CAL) Atellica CH ENZ 2 Calibrator (ENZ 2 CAL) ADVIA Chemistry Enzyme 3 Calibrator (ENZ 3 CAL) Dimension PCP Flex Emit 2000 Siro/Tacro Sample Pretrea Emit 2000 Sirolimus Calibrators Emit 2000 Sirolimus Assay Dimension IGA Flex SCS CKMB CalPak Emit 2000 Digoxin Cals Dimension LA Flex Dimension Sample Probe Cleaner Dimension Reagent Probe Cleaner Dimension Reaction Vessels Dimension® HM Dimension IMT Probe Cleaner Dimension FERR Flex Dimension Chemistry Wash Dimension Sample Diluent Atellica CH A-LYTE Integrated Multisensor (IMT Na K CI) Emit LSD Assays Emit LSD Control Level II Emit LSD Control Level I Emit LSD Cals (10 ml) Atellica IM 1600 Analyzer Atellica IM Cleaner Atellica IM Wash Atellica IM Acid/Base Atellica IM 1300 Analyzer Atellica IM Acid Atellica IM Ancillary Seal Kit Atellica IM Base Atellica IM 1300 Analyzer (Fully Refurbished) Atellica IM 1600 Analyzer (Fully Refurbished) Atellica CH Creatinine_3 (Crea3) Aliquot Wheel Assembly Dimension Creatinine Flex reagent cartridge VITROS Chemistry Products Calibrator Kit 14 box/1 set/6 btls Vista LOCI 4 Cal Vista VB12 Flex Dimension Vista TSH Flex Dimension Vista FT4 Flex Dimension Vista/EXL MULTI 2 SDIL Dimension Vista® Magnesium Flex® reagent cartridge Dimension Vista Estradiol Flex (E2) Dimension Vista Multi 1 Sample Diluent (MULTI 1 SDIL) Dimension DGNA Flex Atellica CH Cholinesterase_2 (CHE_2) Dimension Chemistry III Calibrator Atellica CH CHEM III Calibrator (CHEM III CAL) Atellica CH Total Iron Binding Capacity (TIBC) Atellica CH A1c_3 Calibrator (A1c_3 CAL) ADVIA Chemistry HbA1c Denaturant Reagent (HbA1c Denat) Dimension TPSA Flex Vista TPSA Flex Atellica CH Phencyclidine (Pcp) Assay Atellica CH Vancomycin (Vanc) Assay Atellica CH Phencyclidine (PcpC) Emit II Plus Benzodiazepine Assay Dimension CTNI Flex Dimension LTNI Flex Dimension AHDL Flex Dimension/Dimension Vista CTNI Sample Diluent Dimension TNI Flex Dimension Vista CTNI Sample Diluent Emit tox Salicylic Acid Assay Emit tox Salicylic Acid Calibrators VITROS Chemistry Products Calibrator Kit 13 box/1 set/6 btls Emit 2000 N-Acetylprocainamide Cals Emit 2000 N-Acetylprocainamide Assy Dimension AHDL Cal Dimension Vista ETOH Flex Vista Prolactin Flex (LOCI PRL) Emit Antiepileptic Drug Cal Set Stratus CS CTNI CalPak Atellica CH Chemistry Calibrator (CHEM CAL) ADVIA Chemistry Lithium_2 (LITH_2) Atellica CH Lithium_2 (LITH_2) Emit 2000 Vancomycin Cals Dimension LIPL Cal Dimension CSA Cal Dimension RCRP Cal Dimension TU Flex Dimension T4 Cal Dimension URCA Flex Dimension TU Cal Dimension CHK Flex Emit tox Serum Barbiturate Assay Syva RapidTest d.a.u. TCA Sample Transfer Module Sample Transfer Module Pipette Tips Sample Transfer Module Aliquot Segment Sample Transfer Module Kit for EXL Reagent Management System Dimension® Reagent Management System for EXL Dimension Vista LIPID Cal Dimension LOCI NTP Cal Stratus CS DDMR CalPak Dimension Tacrolimus Calibrator Dimension Tacrolimus Flex reagent cartridge Dimension VALP Flex Atellica CH Valproic Acid (VPA) IMMULITE Probe Wash Module IMMULITE Probe Cleaning Kit IMMULITE 2000 / XPi Probe Cleaning Kit IMMULITE 2000 / XPi Probe Wash Module Dimension ALDL Cal Dimension Vista LITH Flex Dimension Vista Drug 4 Cal Dimension Vista 1500 System Dimension Vista Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge Dimension PBNP Flex Syva RapidTest d.a.u. 4 THC/OPI/COC/AMP Emit II Plus Propoxyphene Assays Atellica CH Propoxyphene (Ppx) Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Dimension GENT Flex Atellica CH Gentamicin (Gent) Vista ENZ5 Cal Atellica CH Revised C-Reactive Protein Assay (RCRP) Dimension RCRP Flex Dimension Glucose Flex Dimension Thyroid Stimulating Hormone Flex Dimension RxL Max with HM & STM Dimension RxL (with or without HM) Dimension RxL Max (with or without HM) Dimension Xpand (with or without HM) Dimension Xpand Plus (with or without HM) Dimension Aspartate Aminotransferase Flex QuikLYTE IMT (Na+/K+/Cl-) Syva RapidTest d.a.u. BAR Dimension Vista IRON Flex Dimension Vista IRON Cal Emit 2000 Valproic Acid Cals Dimension Vista CA Flex Stratus CS Acute Care PBNPM CalPak Stratus CS Acute Care PBNP TestPak Stratus CS Acute Care BHCG CalPak Stratus CS Acute Care BHCG TestPak Stratus CS Acute Care PBNP CalPak Dimension PCHE Flex Dimension Vista PBNP Flex Dimension Vista PBNP Cal Dimension ETOH Flex Atellica CH ETOH Atellica CH Ethyl Alcohol (EtohC) Syva Emit 2000 Mycophenolic Acid Controls Dimension Vista Chemistry 3 Calibrator Dimension Vista Ammonia Flex Dimension AMY Flex SCS CTNI DilPak Emit II Plus Cannabinoid Assay Dimension Vista LOCI CA 15-3 Flex Dimension Vista DRUG 1 Cal Dimension Hemoglobin A1c Assay Dimension Vista Hemoglobin A1c Assay Dimension LOCI TNI Cal Emit Lidocaine Assay Dimension Vista UDAT Cal Dimension Vista BILI Cal Dimension Vista ALPI Cal Dimension ALPI Cal Dimension Vista ALPI Flex Dimension Vista CHEM 2 Cal Dimension METH Flex Dimension EZCR Flex Dimension ECRE Flex Dimension PBNP Cal Dimension BENZ Flex VITROS Chemistry Products Calibrator Kit 12 box/1 set/6 btls Emit Ethosuximide Assay Dimension Vista HAPT Flex Atellica CH Haptoglobin_2 (Hapt_2) ADVIA Chemistry HAPT Dimension Vista UCFP Cal Emit II Plus Methaqualone Assays Dimension Vista LOCI 6 Calibrator Dimension Vista LOCI CA 125 Flex Atellica CH Acetaminophen (Acet) Atellica CH Acetaminophen (AcetC) Dimension EXL LOCI BRAHMS Procalcitonin (PCT) ADVIA® Chemistry Toxicology Calibrators Dimension Drug Cal II Dimension Vista DRUG 2 Cal Dimension Vista EXTC Cal Atellica CH Cocaine Metabolite (Coc) Atellica CH Cocaine Metabolite (CocC) Atellica CH Amphetamines (AmpC) Atellica CH Amphetamines (Amp) Emit II Plus Amphetamine Assays ADVIA Chemistry Enzymatic Creatinine_3 (ECre3) Atellica CH Enzymatic Creatinine_3 (ECre3) Vista ECREA Flex Dimension AMPH Flex Dimension Vista TP Flex Dimension Vista UCFP Flex Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Atellica CH Total Protein_2 (TP_2) ADVIA Chemistry TP_c ADVIA Chemistry TP Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Dimension / Dimension Vista Lipase Calibrator (LIP) Atellica CH Urine Albumin Calibrator (UAlb CAL) ADVIA Chemistry Enzymatic Hemoglobin A1c Calibrator (A1c_E CAL) Dimension Vista Enzymatic Creatinine Calibrator (ECREA CAL) Atellica CH LDL Cholesterol Calibrator (LDLC CAL) Dimension EXL LOCI BRAHMS Procalcitonin Calibrator (LOCI PCT CAL) Dimension Vista High-Sensitivity Troponin I Calibrator (TNIH Cal) ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL) Atellica CH Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL) Atellica CH Enzymatic Hemoglobin A1c_E Calibrator (A1c_E CAL) Dimension EXL LOCI High-Sensitivity Troponin I Calibrator (LOCI TNIH CAL) Atellica CH HDLC Calibrator (HDLC CAL) Dimension Vista OPI Flex Dimension Vista AMPH Flex Dimension Vista COC Flex Dimension Vista BARB Flex Dimension Vista METH Flex Dimension Vista BENZ Flex Dimension Vista EXTC Flex Dimension Vista THC Flex Dimension Vista PCP Flex Dimension Vista sALB Flex reagent cartridge (sALB) Atellica CH Urine Albumin (UAlb) Dimension MYO Cal Dimension CHOL Cal Dimension CHEM II Cal Dimension CHOL Flex Dimension GGT Flex Dimension MG Flex Dimension ALB Flex Dimension IBCT Cal Dimension Special Protein Cal Emit II Plus Phencyclidine Assays Syva Emit Disopyramide Assay ADVIA Chemistry TBIL_2 Atellica CH Total Bilirubin_2 (TBil_2) N Latex ASL Dimension Vista ASL Flex Atellica CH Anti-Streptolysin-O_2 (ASO_2) Atellica CH Anti-Streptolysin-O_3 (ASO_3) Vista LOCI Progesterone Flex (LOCI PROG) ADVIA 1650 HDL CHOLESTEROL ASSAY Dimension MYO Flex Vista CKI Flex Vista MBI Flex Dimension LMMB Flex Dimension MMB Flex Stratus CS DDMR DilPak Emit dau Amphetamine Class Assay

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)