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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 16 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cobas b 123 Fluid Pack COOX 200 | 5169992001 | FDA UDI | Class II | Unknown |
| no MS ISE Calibrator IndirectUrine) | 20763063122 | FDA UDI | Class II | Active |
| Tina-quant Hemoglobin A1cDx Gen.3 | 07559674190 | FDA UDI | Class II | Active |
| Cholesterol | 08057443190 | FDA UDI | Class I | Active |
| Elecsys LH CalSet II | 3561097190 | FDA UDI | Class II | Active |
| Tinaquant 1Antitrypsin ver2 | 5991978190 | FDA UDI | Class II | Active |
| Elecsys DHEAS CalSet | 3000095122 | FDA UDI | Class II | Active |
| Elecsys Anti-HBe | 11820613160 | FDA UDI | Class II | Active |
| Control Set DAT Clinical | 4500873190 | FDA UDI | Class I | Active |
| Prealbumin - Application for C.f.a.s. PAC | 20764655322 | FDA UDI | Class I | Active |
| Roche 9180 ISE SnapPak | 3112349180 | FDA UDI | Class II | Active |
| Elecsys CEA CalSet | 11731645322 | FDA UDI | Class II | Active |
| Lactate Dehydrogenase acc. to IFCC ver.2 | 08057958190 | FDA UDI | Class II | Active |
| Elecsys LH | 07027575190 | FDA UDI | Class I | Active |
| Creatine Kinase | 07442017190 | FDA UDI | Class II | Active |
| Opiates II | 4490894190 | FDA UDI | Class II | Active |
| Pancreatic alpha-amylase liquid | 11876562316 | FDA UDI | Class II | Unknown |
| Elecsys PreciControl HBeAg | 11876376160 | FDA UDI | Class II | Unknown |
| Elecsys FSH | 08932352190 | FDA UDI | Class I | Active |
| Elecsys T4 Assay | 12017709122 | FDA UDI | Class II | Active |
| Elecsys HE4 CalSet | 5950945190 | FDA UDI | Class II | Active |
| Elecsys Vitamin B12 CalCheck | 4836693160 | FDA UDI | Class I | Active |
| Chemstrip 5 OB Test Strips | 11893467160 | FDA UDI | Class I | Active |
| Tinaquant Albumin Gen2 | 5167043190 | FDA UDI | Class II | Active |
| Tg II CalSet | 08991405190 | FDA UDI | Class II | Active |
| Phencyclidine | 20738042122 | FDA UDI | U | Active |
| ONLINE DAT Methadone II | 08058008190 | FDA UDI | Class II | Active |
| ONLINE DAT Benzodiazepines II | 08056927190 | FDA UDI | Class II | Active |
| CoaguChek XS Professional Use Care Kit | 4837975001 | FDA UDI | Class II | Active |
| Elecsys NMID Osteocalcin CalSet | 11972111122 | FDA UDI | Class II | Active |
| CalCheck IGF-1 | 07475993190 | FDA UDI | Class I | Active |
| PreciControl Cardiac II | 4917049160 | FDA UDI | Class I | Active |
| Elecsys Rubella IgM Immunoassay | 4618831160 | FDA UDI | Class II | Active |
| Elecsys AntiTg Calset | 6368603190 | FDA UDI | Class II | Active |
| AlbuminBCP AlbuminBCP | 11815148216 | FDA UDI | Class II | Active |
| Elecsys CA 15-3 II | 07027001190 | FDA UDI | Class II | Active |
| Elecsys HBsAg II | 08814848190 | FDA UDI | Class II | Active |
| Ammonia | 05401739190 | FDA UDI | Class I | Active |
| Elecsys CYFRA 21-1 | 07299966190 | FDA UDI | Class II | Active |
| Chemstrip 9 Urine Test Strips | 11895397160 | FDA UDI | Class II | Active |
| cobas pro e 801 SBL-DL | 08462984001 | FDA UDI | Class I | Active |
| Uric Acid ver.2 | 08058750190 | FDA UDI | Class I | Active |
| Benzodiazepines | 20737984122 | FDA UDI | Class II | Active |
| Glucoquant GlucoseHK | 11929542216 | FDA UDI | Class II | Active |
| Elecsys CEA Assay | 4491777160 | FDA UDI | Class II | Active |
| Elecsys Digoxin Assay | 11820796322 | FDA UDI | Class II | Unknown |
| Cyclosporine Calibrator 0 ng/mL | 20766399122 | FDA UDI | Class II | Active |
| Tinaquant CReactive Protein Gen3 | 4956923190 | FDA UDI | Class II | Active |
| Cardiac CReactive Protein Latex High Sensitive | 4628918190 | FDA UDI | Class II | Active |
| Elecsys Myoglobin STAT CalSet | 11820893122 | FDA UDI | Class II | Active |
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