FDA Device Registration & Listing · Suffern, NY, US · Registration 3033967997
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LCD | Enzyme Immunoassay, Gentamicin | Clinical Toxicology | Class 2 | 862.3450 | 2025-04-04 |
| DGC | Ige, Antigen, Antiserum, Control | Immunology | Class 2 | 866.5510 | 2025-04-04 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | Microbiology | Class 2 | 866.3510 | 2025-04-04 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2025-04-04 |
| LCR | Fluorescent Immunoassay, Tobramycin | Clinical Toxicology | Class 2 | 862.3900 | 2025-04-04 |
| JLS | Radioimmunoassay, Progesterone | Clinical Chemistry | Class 1 | 862.1620 | 2025-04-04 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | Clinical Chemistry | Class 1 | 862.1680 | 2025-04-04 |
| CEP | Radioimmunoassay, Luteinizing Hormone | Clinical Chemistry | Class 1 | 862.1485 | 2025-04-04 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | Clinical Chemistry | Class 2 | 862.1377 | 2025-04-04 |
| CGN | Acid, Folic, Radioimmunoassay | Clinical Chemistry | Class 2 | 862.1295 | 2025-04-04 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | Clinical Chemistry | Class 1 | 862.1300 | 2025-04-04 |
| JIT | Calibrator, Secondary | Clinical Chemistry | Class 2 | 862.1150 | 2025-04-04 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | Microbiology | Class 2 | 866.3780 | 2025-04-04 |
| CDP | Radioimmunoassay, Total Triiodothyronine | Clinical Chemistry | Class 2 | 862.1710 | 2025-04-04 |
| DKB | Calibrators, Drug Mixture | Clinical Toxicology | Class 2 | 862.3200 | 2025-04-04 |
| CEC | Radioimmunoassay, Free Thyroxine | Clinical Chemistry | Class 2 | 862.1695 | 2025-04-04 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2025-04-04 |
| CEW | Radioimmunoassay, Parathyroid Hormone | Clinical Chemistry | Class 2 | 862.1545 | 2025-04-04 |
| CDD | Radioassay, Vitamin B12 | Clinical Chemistry | Class 2 | 862.1810 | 2025-04-04 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | Clinical Toxicology | Class 2 | 862.3880 | 2025-04-04 |
| DDR | Myoglobin, Antigen, Antiserum, Control | Immunology | Class 2 | 866.5680 | 2025-04-04 |
| KHQ | Radioassay, Triiodothyronine Uptake | Clinical Chemistry | Class 2 | 862.1715 | 2025-04-04 |
| JZO | System, Test, Thyroid Autoantibody | Immunology | Class 2 | 866.5870 | 2025-04-04 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | Clinical Chemistry | Class 1 | 862.1625 | 2025-04-04 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | Class 1 | 862.2160 | 2025-04-04 |
| LEH | Radioimmunoassay, Vancomycin | Clinical Toxicology | Class 2 | 862.3950 | 2025-04-04 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2025-04-04 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Clinical Chemistry | Class 2 | 862.1690 | 2025-04-04 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | Clinical Toxicology | Class 2 | 862.3350 | 2025-04-04 |
| GJS | Test, Time, Prothrombin | Hematology | Class 2 | 864.7750 | 2025-03-31 |
No official correspondent registered.
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K905612 | Ventrex Laboratories, Inc. | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | 1991-02-21 |
| K842125 | Kallestad Laboratories, Inc. | ALLERCOAT ALLERGEN DISCS | 1984-06-07 |
| K873780 | Labsystems, Inc. | MODIFICATION RUBELLA IGM EIA TEST KIT | 1987-10-15 |
| K103744 | Quantimetrix Corp. | DROPPER A1C DIABETES CONTROL | 2011-05-12 |
| K981281 | Roche Diagnostics GmbH | ELECSYS CALCHECK FERRITIN | 1998-04-24 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0081-2017 | Siemens Healthcare Diagnostics, Inc. | 2 | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD ---
For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age. |
| Z-0082-2017 | Siemens Healthcare Diagnostics, Inc. | 2 | SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD ---
For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age |
| Z-0007-2008 | Tosoh Bioscience Inc | 1 | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. |
| Z-0024-2007 | Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila | 2 | FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. |
| Z-0024-2015 | Siemens Healthcare Diagnostics, Inc. | 2 | Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3003561301 | B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, DE |
| 2432235 | Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, US |
| 3002806944 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED | LLANBERIS Wales, GB |
| 3002642396 | Ortho Clinical Diagnostics | Singapore South West, SG |
| 8020888 | Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin, IE |
3033967997 when referencing this establishment in official correspondence.