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Sign in to claim this brandRoche Diagnostics Corp.
US
Last updated May 23, 2026
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Catalogue (1711)
Page 25 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reference electrode | 03149501001 | FDA UDI | Class II | Active |
| ONLINE TDM Phenobarbital | 3510620190 | FDA UDI | Class II | Unknown |
| Albumin BCP | 5599261190 | FDA UDI | Class II | Active |
| ONLINE TDM Acetaminophen Gen2 | 6769942190 | FDA UDI | Class II | Active |
| Serum proteins T Standard | 20737267322 | FDA UDI | Class II | Active |
| Elecsys Free PSA CalCheck | 03500373190 | FDA UDI | Class III | Unknown |
| PreciControl Release HTLV | 09366989190 | FDA UDI | U | Active |
| Ethanol Gen.2 | 08057630190 | FDA UDI | Class II | Active |
| cobas® Buffer Negative Control Kit | 07002238190 | FDA UDI | Class II | Active |
| cobas b 123 Sensor Cartridge BG/ISE/GLU | 05331781001 | FDA UDI | Class II | Unknown |
| Self-Contained ISE Support Box | 08126232001 | FDA UDI | Class I | Active |
| cobas i 601 | 10271582001 | FDA UDI | Class I | Active |
| cobas® NHP Negative Control Kit | 1.0 | FDA UDI | Class II | Active |
| Lipase colorimetric | 7041918190 | FDA UDI | Class I | Active |
| Accu-Chek Inform II Instrument with RF card | 04882458001 | FDA UDI | Class II | Active |
| Chemstrip 9 Urine Test Strips | 11895427160 | FDA UDI | Class II | Active |
| Aspartate Aminosransferase acc. to IFCC with pyridoxal phosphate activation | 08056838190 | FDA UDI | Class II | Active |
| PreciControl beta-Amyloid (1-42) II | 08821968190 | FDA UDI | Class I | Active |
| Sodium Electrode | 03111598180 | FDA UDI | Class II | Active |
| no MS (ISE Reference Electrolyte) | 20738085122 | FDA UDI | Class II | Active |
| cobas b 221 <2> system | 3337111001 | FDA UDI | Class II | Active |
| cobas b 221 GLU/LAC Cassette | 03260887184 | FDA UDI | Class I | Active |
| ONLINE DAT Methaqualone | 08814708190 | FDA UDI | Class II | Active |
| Elecsys beta-Amyloid (1-42) CSF II | 08821941190 | FDA UDI | Class II | Active |
| Albumin BCG method | 11929631216 | FDA UDI | Class II | Unknown |
| Lactate dehydrogenase liquid acc to IFCC | 3002209122 | FDA UDI | Class II | Active |
| Elecsys Beta-Amyloid (1-42) CSF II | 08821909160 | FDA UDI | Class II | Active |
| Elecsys Anti-HBc Immunoassay | 04927826160 | FDA UDI | Class II | Unknown |
| cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC | 05170478001 | FDA UDI | Class II | Unknown |
| ONLINE DAT Lysergic Acid Diethylamide | 08764778190 | FDA UDI | Class II | Active |
| UreaBUN | 5171873190 | FDA UDI | Class II | Active |
| Elecsys Beta-CrossLaps/serum | 09005781190 | FDA UDI | Class I | Active |
| CSAII Cyclosporine II | 4340892190 | FDA UDI | Class II | Active |
| CEDIA Carbamazepine II | 11815601216 | FDA UDI | Class II | Unknown |
| cobas® MPX (96 tests) | 06998909190 | FDA UDI | N/A | Active |
| cobas omni Wash Reagent WASH) | 1.0 | FDA UDI | Class II | Active |
| Elecsys CalCheck FSH | 11776827160 | FDA UDI | Class II | Active |
| Elecsys HBsAg Confirmatory Test | 11820648122 | FDA UDI | Class II | Unknown |
| cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System | 07000979190 | FDA UDI | Class II | Active |
| Protein Total Protein in UrineCerebrospinal Fluid | 11877801160 | FDA UDI | Class II | Active |
| Tinaquant Haptoglobin ver2 | 5992001190 | FDA UDI | Class II | Active |
| cobas Zika (480 tests) | 07972466190 | FDA UDI | N/A | Active |
| cobas IT 1000 | 04420306001 | FDA UDI | Class I | Unknown |
| Elecsys HIV combi PT | 08924180160 | FDA UDI | Class II | Active |
| Roche 9180 Lithium Electrode | 3110664180 | FDA UDI | Class II | Active |
| Tina-quant Alpha 1-Acid Glycoprotein Gen.2 | 03333795190 | FDA UDI | Class I | Active |
| alpha-Amylase EPS ver.2 | 5167027190 | FDA UDI | Class II | Active |
| Elecsys CA 153 II CalSet | 3045846122 | FDA UDI | Class II | Active |
| Modification To:cobas Integra Hdl-Cholesterol Plus 2nd Generation | K012286 | FDA 510(k) | Class I | Active |
| Preciset Dat Amphetamine Calibrators; Cfas Dat Qualitative Amphetamine Calibrators | K033165 | FDA 510(k) | Class II | Active |
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