FDA Registration
Active
🇬🇧 United Kingdom
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
Reg #: 3002806944
·
FEI: 3002806944
·
Expires 2026
Products
85
Proprietary Names
383
Establishment Types
3
Classifications
85
Registration Details
- Registration Name
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
- Registration Number
- 3002806944
- FEI Number
- 3002806944
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GLYN RHONWY
- City
- LLANBERIS Wales
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K091984
- PMA Number
- P210019
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
US Agent
- Business Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Contact Name
- Mary Seeger
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
- [email protected]
- Phone
- 914 3254329
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2009-11-05 |
| Radioimmunoassay, Thyroxine-Binding Globulin | CEE | Class 2 | Clinical Chemistry | No | 2006-12-15 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2005-05-12 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-08-20 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2025-12-12 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2025-12-12 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2003-03-03 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2005-05-12 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2008-09-18 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2026-06-19 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2003-03-03 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2005-05-12 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2003-03-03 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2003-03-03 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2005-05-12 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2005-05-12 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2005-05-12 |
| Radioimmunoassay, Gastrin | CGC | Class 1 | Clinical Chemistry | No | 2005-05-12 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2005-05-12 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2023-06-06 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2023-06-06 |
| Column Chromatography & Color Development, Hydroxyproline | JMM | Class 1 | Clinical Chemistry | No | 2005-05-12 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2003-03-03 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2011-03-25 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2010-01-04 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2011-03-25 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2009-05-28 |
| Radioimmunoassay, Immunoglobulins (D, E) | JHR | Class 2 | Immunology | No | 2009-12-10 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2005-05-12 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2003-03-03 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2003-03-03 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2013-04-10 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 1998-02-12 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2005-05-12 |
| Radioimmunoassay, Calcitonin | JKR | Class 2 | Clinical Chemistry | No | 2005-05-12 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2008-09-22 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2011-03-25 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2009-05-19 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2009-05-19 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2009-05-19 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2005-05-12 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2005-05-12 |
| Assay, Erythropoietin | GGT | Class 2 | Hematology | No | 2005-05-12 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2005-05-12 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2018-02-20 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2003-03-03 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2005-05-12 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2005-05-12 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2005-05-12 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2005-05-12 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2005-05-12 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2006-08-04 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2008-09-22 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2009-03-12 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2005-05-17 |
| Albumin, Rhodamine, Antigen, Antiserum, Control | DFJ | Class 2 | Immunology | No | 2026-04-15 |
| Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH | Class 2 | Clinical Chemistry | No | 2003-03-03 |
| System, Test, Thyroglobulin | MSW | Class 2 | Immunology | No | 2005-05-12 |
| Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | LOK | Class 3 | Unknown | No | 2006-11-28 |
| Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | MTF | Class 3 | Unknown | No | 2005-05-12 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2005-05-12 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2011-03-25 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2006-08-04 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2026-01-06 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2009-07-02 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2009-05-19 |
| Radioassay, Intrinsic Factor Blocking Antibody | LIG | Class 2 | Clinical Chemistry | No | 2006-08-04 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2003-03-03 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2005-06-27 |
| Ige, Peroxidase, Antigen, Antiserum, Control | DGO | Class 2 | Immunology | No | 2009-05-19 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2009-05-19 |
| Radioimmunoassay, Human Placental Lactogen | JMF | Class 2 | Clinical Chemistry | No | 2009-05-19 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2009-05-19 |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | Class 2 | Immunology | No | 2009-05-19 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2009-05-19 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2009-05-19 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2009-05-19 |
| Radioimmunoassay, Cyclic Gmp | CGT | Class 2 | Clinical Chemistry | No | 2009-05-19 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2009-05-19 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2009-05-19 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2009-05-19 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2009-05-19 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2011-01-21 |
| Radioimmunoassay, Tobramycin | KLB | Class 2 | Clinical Toxicology | No | 2006-12-15 |
| Antibody Igm,If, Cytomegalovirus Virus | LKQ | Class 2 | Microbiology | No | 2010-12-20 |
Proprietary Names
IMMULITE 2000 Cherry F242
IMMULITE 2000 Lamb F88
IMMULITE 2000 Trout F204
IMMULITE 2000 Turkey Meat F284
IMMULITE 2000 Chestnut F299
IMMULITE 2000 Cabbage F216
IMMULITE 2000 Pineapple F210
IMMULITE 2000 Lemon F208
IMMULITE 2000 Grapefruit F209
IMMULITE 2000 Watermelon F329
IMMULITE 2000 Pumpkin F225
IMMULITE 2000 Cheese, Mold Type F82
IMMULITE 2000 Spinach F214
IMMULITE 2000 Cucumber F244
IMMULITE 2000 Pear F94
IMMULITE 2000 Plum F255
IMMULITE 2000 Peach F95
IMMULITE 2000 Sweet Potato F54
IMMULITE 2000 Coffee F221
IMMULITE 2000 Grape F259
IMMULITE 2000 Sole F337
IMMULITE 2000 Chocolate F105
IMMULITE 2000 Broccoli F260
IMMULITE 2000 Red Snapper F381
IMMULITE 2000 Haddock F42
IMMULITE 2000 Lima Bean F182
IMMULITE 2000 Black Pepper F280
IMMULITE 2000 Avocado F96
IMMULITE 2000 Thyroid Uptake (TU)
IMMULITE 2000 Blomia Tropicalis D20, 20 size
IMMULITE 2000 Chicken Feathers E85, 20 size
IMMULITE 2000 nDer p1 A310, 20 Size
IMMULITE 2000 Brazilian Peppertree T401, 20 size
IMMULITE 2000 nDer f2 A302, 20 size
IMMULITE 2000 Penicillium Brevi-Compactum M305, 20 size
IMMULITE 2000 nCan f 1 A174, 20 size
IMMULITE 2000 nPen m 1, F351, 20 size
IMMULITE 2000 Rabbit Bush W36, 20 size
IMMULITE 2000 Turkey Feathers E89, 20 size
IMMULITE 2000 Parrot Feathers E91, 20 size
IMMULITE 2000 Pigeon Droppings E7, 20 size
IMMULITE 2000 nDer f 1 A295, 20 size
IMMULITE 2000 Aureobasidium Pullulans M12, 20 size
IMMULITE 2000 nFel d 1 A345, 20 size
IMMULITE 2000 nAsp r 1 A3050, 20 size
IMMULITE 2000 Tobacco O201, 20 size
IMMULITE 2000 Canary feather E201, 20 size
IMMULITE 2000 Loblolly Pine T43, 20 size
IMMULITE 2000 Budgerigar Feathers E78, 20 size
IMMULITE 2000 nDer p 2 A316, 20 size
IMMULITE
IMMULITE 2000 OM-MA Sample Diluent (OV DIL)
IMMULITE H.Pylori IgG Calibration Verification Material (HPG CVM)
IMMULITE Rubella Quantitative IgG Calibration Verification Material (RUB CVM)
IMMULITE Toxoplasma Quantitative IgG Calibration Verification Material (TXP CVM)
Atellica IM aTPOII Diluent (aTPOII DIL)
Atellica IM aTPOII Quality Control (aTPOII QC)
Atellica IM aTPOII Master Curve Material (aTPOII MCM)
ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM)
ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)
ADVIA Centaur aTPOII Diluent (aTPOII DIL)
ADVIA Centaur aTPOII Quality Control (aTPOII QC)
Atellica IM Anti-Thyroid Peroxidase II (aTPOII)
IMMULITE 2000 Digoxin (DGX)
IMMULITE 2000 GENTAMICIN
IMMULITE 2000 IGF-I Sample Diluent (IGF DIL)
IMMULITE 2000 IGF-1 (IGF)
IMMULITE 2000 IGFBP-3 (BP3)
IMMULITE 2000 IGF-1 Sample Diluent (IGF DIL)
IMMULITE 2000 Growth Hormone (GRH)
IMMULITE 2000 IGF-I (IGF)
Third Generation TSH Control Module (TSH QC)
IMMULITE 2000 Anti-TPO Ab Calibration Verification Material (ATA CVM)
IMMULITE 2000 Thyroglobulin Calibration Verification Material (TG CVM)
IMMULITE 2000 Anti-TG Ab Calibration Verification Material (ATG CVM)
IMMULITE 2000 BR-MA
Cinnamon (F220L2); Flounder (F147L2);
Brewer's Yeast (F403L2); Cantaloupe (F102L2);
Halibut (F303L2); Mushroom (F212L2)
Green Bean (F315L2); Green Pepper (F263L2)
IMMULITE 2000 3gAllergy Specific IgE
Sugar Cane (F21L2); Yogurt (F360L2)
Pinto Beans (F300L2); Red Kidney Bean (F287L2)
IMMULITE 2000 LH (LH)
IMMULITE 2000 Homocysteine Sample Diluent (HCY DIL)
IMMULITE 2000 Homocysteine (HCY)
IMMULITE 2000 Ferritin (FER)
IMMULITE Calcitonin Calibration Verification Material (CAL CVM)
IMMULITE Prostatic Acid Phosphatase Calibration Verification Material (PAP CVM)
IMMULITE 2000 Beta-2 Microglobulin (BMG)
IMMULITE Beta-2 Microglobulin Control Module (BMG QC)
ACTH Control Module (ACT QC)
IMMULITE 2000 Unconjugated Estriol
IMMULITE Myoglobin CVM (MYO CVM)
IMMULITE Albumin CVM (ALB CVM)
IMMULITE 2000 Specific Allergens
IMMULITE Third Generation TSH CVM (TSH CVM)
IMMULITE DHEA-SO4 CVM (DHS CVM)
IMMULITE Intact PTH CVM (iPT CVM)
IMMULITE 2000 HCG (HCG)
IMMULITE 2000 HCG Sample Diluent (HCG DIL)
IMMULITE HCG Control Module (HCG QC)
IMMULITE 2000 VALPROIC ACID (VAL)
IMMULITE 2000 Androstenedione Calibration Verification Material (AND CVM)
IMMULITE 2000 Troponin I Calibration Verification Material (TPI CVM)
IMMULITE 2000 Gastrin (GAS)
IMMULITE Rubella Quant IgG
ADVIA Centaur HBc Total 2 (HBcT2)
Atellica IM HBc Total 2 Quality Control (HBcT2 QC)
Atellica IM HBc Total 2 (HBcT2)
ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC)
IMMULITE 2000 Rubella IgM (RUM)
IMMULITE Rubella IgM Control Module (RUM QC)
IMMULITE Pyrilinks-D Control Module (DPD QC)
IMMULITE 2000 Pyrilinks-D (DPD)
IMMULITE 2000 HCG Sample Diluent
IMMULITE HCG Control Module
IMMULITE/IMMULITE 1000 HCG Sample Diluent
IMMULITE 2000 HCG
IMMULITE/IMMULITE 1000 HCG
HCG-Human chorionic gonadotropin
IMMULITE 2000 ANTI-TPO
IMMULITE 2000 Free T3 Calibration Verification Material (FT3 CVM)
IMMULITE Gastrin Calibration Verification Material (GAS CVM)
IMMULITE 2000 LH Calibrator Verification Material (LH CVM)
IMMULITE® 2000 3gAllergyTM Specific IgE Universal Kit
rMal d 4, (A796 Apple, Malus domestica)
rBet v 2, (A127 Birch pollen, Betula verrucose)
rPru av 1, (A597 Cherry, Prunus avium)
rPru av 3, (A599 Cherry, Prunus avium)
rPru av 4 (A600 Cherry, Prunus avium)
n Pru p 3, (A603 Peach, Prunus persica)
rMal d 1 (A464 Apple, Malus domestica)
IMMULITE 2000 Theophylline (THE)
IMMULITE 2000 Vancomycin
Vancomycin
IMMULITE 2000 Vancomycin Sample Diluent
Unconjugated Estriol Calibration Verification Material (UE3 CVM)
IMMULITE Syphilis Screen Control Module
IMMULITE 2000 Syphilis Screen
Cortisol Control Module
IMMULITE SHBG Control Module (SBG QC)
IMMULITE 2000 SHBG (SBG)
IMMULITE 2000 Mixed Allergen Panels
Oregano (F283), Parsley (F86), Pine Nut (F253),
Vanilla (F234)
3gAllergy Specific Allergens: Basil (F269), Cacao (F93),
IMMULITE 2000 HBsAg (HBS)
IMMULITE 2000 HBsAg Confirmatory
Total IgE Control Module
IMMULITE Total IgE Control Module (TIE QC)
IMMULITE Serum Drug Control Module
IMMULITE 2000 Phenytoin (PHN)
IMMULITE 2000 ACTH (ACT)
IMMULITE 1000 Sycamore T11 (T11)
IMMULITE 2000 L2SNC Specific IgE Negative Control
IMMULITE 2000 3gAllergy Specific IgE (SPE)
IMMULITE 2000 DC2L Specific IgE Positive Control
IMMULITE 2000 MC6L Specific IgE Positive Control
IMMULITE 2000 DC1L Specific IgE Positive Control
IMMULITE 2000 Prolactin (PRL)
IMMULITE 2000 Prolactin Sample Diluent (PRL DIL)
IMMULITE Homocysteine CVM (HCY CVM)
IMMULITE Insulin CVM (INS CVM)
IMMULITE Growth Hormone CVM (GRH CVM)
IMMULITE HCG CVM (HCG CVM)
IMMULITE 2000 Total Testosterone Calibrator Verification Material (TES CVM)
IMMULITE 2000 C-Peptide Calibrator Verification Material (CPE CVM)
IMMULITE 2000 SHBG Calibrator Verification Material (SBG CVM)
IMMULITE 2000 Anti-CCP Calibration Verification Material (CCP CVM)
IMMULITE 2000 Anti-CCP IgG (CCP)
IMMULITE 2000 Multi-Diluent 2
ADVIA Centaur Multi-Diluent 3 (M-Dil 3)
ADVIA Centaur Multi-Diluent 11 (M-Dil 11)
Blood Gas Systems
600 Series Blood Gas
ADVIA Centaur Multi-Diluent 15
IMMULITE 2000 IgG/IgM Sample Diluent
Atellica IM Multi-Diluent 12 (M-Dil 12)
Atellica IM Multi-Diluent 13 (M-Dil 13)
Atellica IM Multi-Diluent 2 (M-Dil 2)
Atellica IM Multi-Diluent 1 (M-Dil 1)
Atellica IM Multi-Diluent 10 (M-Dil 10)
Atellica IM Multi-Diluent 11 (M-Dil 11)
Atellica IM Multi-Diluent 3 (M-Dil 3)
Atellica IM Multi-Diluent 15 (M-Dil 15)
ADVIA Centaur Multi-Diluent 10 (M-Dil 10)
ADVIA Centaur Multi-Diluent 1 (M-Dil 1)
Atellica HEMA Diluent (HEMA Diluent)
IMMULITE 2000 Multi-Diluent 1
ADVIA Centaur Multi-Diluent 2 (M-Dil 2)
MAGIC LITE INTACT PTH DILUENT
IMMULITE Calcitonin Control Module (CAL QC)
IMMULITE 2000 Calcitonin (CAL)
IMMULITE 2000 Free PSA (fPS)
IMMULITE 2000 Carcinoembryonic Antigen (CEA)
IMMULITE 2000 Phenobarbital (PHE)
IMMULITE 2000 Systems Diluent Tube Caps
Atellica CH A-LYTE IMT Cleaner
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
IMMULITE 2000 Herpes I & II IgG (HVG)
IMMULITE PSA Calibration Verification Material (PSA CVM)
IMMULITE 2000 OM-MA Calibration Verification Material (OV CVM)
IMMULITE 2000 BR-MA Calibration Verification Material (BRM CVM)
IMMULITE 2000 AFP Calibration Verification Material (AF CVM)
IMMULITE 2000 Toxoplasma Quantitative IgG (TXP)
IMMULITE Toxoplasma Quantitative IgG Control Module (TXP QC)
IMMULITE 2000 Erythropoietin (EPO)
IMMULITE/IMMULITE 1000 Erythropoietin (EPO) Sample Diluent
IMMULITE EPO
IMMULITE EPO Control Module
IMMULITE 2000 Progesterone (PRG)
IMMULITE 2000 T4 (TT4)
Dimension T4 Flex
IMMULITE 2000 C-Peptide Sample Diluent (PEP DIL)
IMMULITE C- Peptide Control Module (CPE QC)
IMMULITE 2000 Folic Acid (FOL)
IMMULITE 2000 Folic Acid /Vitamin B12 Sample Diluent
IMMULITE Ascorbic Acid (Ascorbic Acid)
IMMULITE 2000 TSIIMMULITE 2000 TSI Calibration Verification Material (TSI CVM)
IMMULITE 2000 CMV IgG
IMMULITE/IMMULITE 1000 Free T4
IMMULITE 2000 OM-MA (OV)
IMMULITE 2000 Myoglobin (MYO)
Total IgE
IMMULITE 2000 Total IgE
IMMULITE 2000 Troponin I (TPI)
IMMULITE 2000 Androstenedione (AND)
IMMULITE 2000 C-Peptide (PEP)
ADVIA Centaur C-peptide (CpS)
Atellica IM C-peptide (CpS)
IMMULITE 2000 Free T3 (FT3)
IMMULITE 2000 Total Testosterone (TES)
IMMULITE 2000 Free PSA Calibration Verification Material (Fps CVM)
Progesterone Calibration Verification Material (CVM)
IMMULITE 2000 TSH Sample Diluent (TSH DIL)
IMMULITE 2000 Rapid TSH (RTH)
IMMULITE High Sensitivity C-Reactive Protein Control Module (hsC QC)
IMMULITE 2000 High Sensitivity C-Reactive Protein (hsC)
IMMULITE 2000 High Sensitivity CRP (hsC)
IMMULITE 2000 High Sensitivity C-Reactive Protein Sample Diluent (hsC DIL)
IMMULITE 2000 DHEA-SO4 (DHS)
IMMULITE 2000 Albumin (ALB)
IMMULITE Albumin Control Module (ALB QC)
IMMULITE 2000 Toxoplasma IgM (TXM)
IMMULITE PAP Control Module
IMMULITE 2000 PAP (PAP)
IMMULITE 2000 PAP
IMMULITE 2000 Thyroglobulin Sample Diluent (TG DIL)
IMMULITE 2000 Thyroglobulin (TG)
IMMULITE 2000 3gAllergy Specific IgE (SPE CVM)
IMMULITE 2000 Total IgE (TIE CVM)
IMMULITE 2000 AFP (AF)
IMMULITE 2000 AFP
IMMULITE AFP Control Module
IMMULITE 2000 PSA (PTS)
IMMULITE 2000 Free T4 (F4)
IMMULITE 2000 Systems Third Generation TSH
IMMULITE Turbo CK-MB
DOUBLE ANTIBODY ALBUMIN
IMMULITE Thyroid Control Module
IMMULITE PAP Control Module (PAP QC)
Atellica IM aTgII Master Curve Material (aTgII MCM)
ADVIA Centaur aTgII Quality Control (aTgII QC)
Atellica IM Anti-Thyroglobulin II (aTgII)
Atellica IM aTgII Quality Control (aTgII QC)
ADVIA Centaur aTgII Master Curve Material (aTgII MCM)
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
IMMULITE 2000 FSH (FSH)
IMMULITE 2000 FSH Sample Diluent (FSH DIL)
IMMULITE 2000 ACTH Calibrator Verification Material (ACT CVM)
IMMULITE 2000 Thyroglobulin
IMMULITE Thyroglobulin Sample Diluent
IMMULITE Thyroglobulin
IMMULITE Thyroglobulin Control Module
IMMULITE Thyroglobulin Control Module (TG QC)
F291 Cauliflower, F279 Chili Pepper, F50 Chub Mackerel
Allergen - F237 Apricot, F261 Asparagus, F288 Blueberry
F270 Ginger, F306 Lime, F65 Perch, F236 Whey
IMMULITE 2000 Intact PTH (iPT)
IMMULITE 2000 Intact PTH Sample Diluent (iPT DIL)
IMMULITE Intact PTH Control Module (iPT QC)
Dimension Vista® Acid Clean Flex® reagent cartridge
IMMULITE 2000 Prolactin Calibrator Verification Material (PRL CVM)
IMMULITE 2000 IGF-I Calibration Verification Material (IGF CVM)
IMMULITE 2000 Free T4 Calibrator Verification Material (FT4 CVM)
Cephalosporium acremonium
Poplar
Aspergillus niger
Careless weed
IMMULITE 2000 Allergens
Sunflower
Saltbush
IMMULITE Probe Wash Module
IMMULITE Probe Cleaning Kit
IMMULITE 2000 / XPi Probe Cleaning Kit
IMMULITE 2000 / XPi Probe Wash Module
Atellica IM Thyroglobulin (Tg)
Atellica IM Tg Master Curve Material (Tg MCM)
IMMULITE 2000 Anti-HBc IgM (BcM)
IMMULITE Vitamin B12
IMMULITE 2000 VITAMIN B12
IMMULITE 2000 Digitoxin (DGT)
IMMULITE 2000 Cortisol (COR)
IMMULITE 2000 Carbamazepine (CMP)
IMMULITE 2000 Red Mulberry T71
IMMULITE 2000 Stemphylium Solani M88
IMMULITE 2000 American Cockroach I206
IMMULITE 2000 Locust tree T280
IMMULITE 2000 Hormodendrum Hordei M45
IMMULITE 2000 Live Oak T103
IMMULITE 2000 Bayberry Sweet Gale T218
IMMULITE 2000 Dog Fennel W46
IMMULITE 2000 Privet T210
IMMULITE 2000 White Bald Cypress T37
IMMULITE 2000 Baccharis W67
IMMULITE Insulin Control Module (INS QC)
IMMULITE 2000 Insulin Sample Diluent (INS DIL)
IMMULITE 2000 Insulin (INS)
Vista FSH Flex
IMMULITE® 2000 FSH
IMMULITE® 2000 FSH Sample Diluent
IMMULITE® / IMMULITE® 1000 FSH
IMMULITE CEA CVM (CEA CVM)
IMMULITE 2000 Anti-TG Ab
Anti-thyroglobulin antibody
IMMULITE 2000 Anti-HBs (aBs)
IMMULITE 2000 FSH CVM (FSH CVM)
IMMULITE 2000 TBG CVM (TBG CVM)
IMMULITE 2000 Estradiol CVM (E2 CVM)
IMMULITE 2000 Total T4 CVM (TT4 CVM)
IMMULITE 2000 Total T3 CVM (T3 CVM)
IMMULITE 2000 TOBRAMYCIN
IMMULITE Gastrin Control Module (GAS QC)
IMMULITE IgF Control Module (IGF QC)
IMMULITE TBG Control Module
IMMULITE TBG Control Module (TBG QC)
IMMULITE TBG Sample Diluent
IMMULITE TBG Sample Diluent (TBG DIL)
IMMULITE 2000 TBG
IMMULITE 2000 TBG (TBG)
IMMULITE TBG
IMMULITE 2000 IGFBP-3 Calibration Verification Material (BP3 CVM)
IMMULITE 2000 Ferritin Calibration Verification Material (FER CVM)
Sex Hormone Bind Globulin (SHBG)
IMMULITE SHBG (Sex Hormone Bind Globulin)
IRMA Count SHBG (Sex Hormone Bind Globulin)
IMMULITE CMV IgG Control Module
IMMULITE CMV IgG
IMMULITE CMV IgG Control Module (CVG QC)
IMMULITE 2000 Rubella Quantitative IgG (RUB)
IMMULITE Rubella IgG Control Module (RUB QC)
E220 (Cat Serum Albumin, Fel d 2)
Specific Allergens:
A482 (Native Ole e 1)
A89 (Native Bet v 1)
A753 (Native Art v 1)
E221 (Dog Serum Albumin, Can f 3)
IMMULITE 2000 H. Pylori IgG (HPG)
IMMULITE H. Pylori IgG Control Module (HPG QC)
IMMULITE 2000 Anti-HBc (aBC)
IMMULITE Vitamin B12 Calibration Verification Material (VB CVM)
IMMULITE 2000 Folic Acid Calibration Verification Material (FOL CVM)
IMMULITE Cortisol Calibration Verification Material (COR CVM)
Atellica IM CMV IgM Quality Control (CMV IgM QC)
Atellica IM CMV IgM (CMV IgM)
IMMULITE 2000 CMV IgM (CMM)
ADVIA Centaur CMV IgM (CMV IgM)
ADVIA Centaur CMV IgM Quality Control (CMV IgM QC)
IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (hsC CVM)
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material (BMG CVM)
IMMULITE 2000 Estradiol Sample Diluent (E2 DIL)
IMMULITE 2000 Estradiol (E2)
IMMULITE Estradiol Control Module (E2 QC)
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198