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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
Address
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Website
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PRRC Contact
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Catalogue (1711)

Page 7 of 35
DeviceModel / ReferenceRegistriesClassStatus
Tina-quant D-Dimer 3001245322
FDA UDI
Class IIActive
Preciset TDM II 3375781190
FDA UDI
Class IIActive
Cfas HbA1c 4528417190
FDA UDI
Class IIActive
Elecsys Anti-TSHR CalCheck 05129397160
FDA UDI
Class IActive
Elecsys HE4 CalCheck 5 5809452160
FDA UDI
Class IActive
total PSA Calset II 04485220160
FDA UDI
Class IIIActive
Glucose HK 4657527190
FDA UDI
Class IIActive
Preciset sTfR 12148331122
FDA UDI
Class IIActive
Elecsys HIV Duo 08836973162
FDA UDI
UActive
Tinaquant Apolipoprotein A1 ver2 3032566122
FDA UDI
Class IIActive
Lipase colorimetric assay 05401704190
FDA UDI
Class IActive
Carbamazepine 20737828322
FDA UDI
Class IIActive
CalSet FT4 IV 09043292160
FDA UDI
Class IIActive
Chemstrip 10 MD Test Strips 3260763160
FDA UDI
Class IIActive
cobas b 221 Chloride Electrode 3111571180
FDA UDI
Class IIActive
RF Control Set 3005496122
FDA UDI
Class IIActive
AMYP Amylase EPS Pancreatic 20766623322
FDA UDI
Class IIActive
Tinaquant C4 11875051216
FDA UDI
Class IIActive
cobas i 601 SBL 10271574001
FDA UDI
Class IActive
Tinaquant IgG Gen2 3507378190
FDA UDI
Class IIActive
cobas Buffer Negative Control Kit 09051953190
FDA UDI
Class IIActive
CalSet Total-Tau 07357010190
FDA UDI
Class IIActive
OPI Opiates 3002000 20767158122
FDA UDI
Class IIActive
Creatinine plus ver2 5168589190
FDA UDI
Class IIActive
HDL-Cholesterol plus 3rd generation 05401488190
FDA UDI
Class IActive
Ammonia II 08058024190
FDA UDI
Class IActive
Elecsys Estradiol III 07027249190
FDA UDI
Class IActive
Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation 5531446190
FDA UDI
Class IIActive
Tina-quant Transferrin ver. 2 08058733190
FDA UDI
Class IIActive
Phenytoin 4490932190
FDA UDI
Class IIActive
Elecsys TSH 08429324160
FDA UDI
Class IIActive
Elecsys LH 11732234122
FDA UDI
Class IActive
Bilirubin Total Gen.3 10421428190
FDA UDI
Class IIActive
PreciControl CMV IgM 4784626190
FDA UDI
Class IActive
Elecsys Cortisol CalCheck 11875132122
FDA UDI
Class IIActive
PreciControl Release HBsAg II 09366717190
FDA UDI
UActive
Potassium Electrode 3111628180
FDA UDI
Class IIActive
Elecsys beta-CrossLaps CalCheck 3140652122
FDA UDI
Class IActive
Ionify CalSet Steroids and Vitamin D 09637273160
FDA UDI
Class IIActive
Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 5850819190
FDA UDI
Class IIActive
Lithium 4679598190
FDA UDI
Class IIActive
Elecsys Vitamin D CalSet 6506798160
FDA UDI
Class IIActive
Creatinine Jaff Gen2 6407137190
FDA UDI
Class IIActive
Elecsys T4 09007784190
FDA UDI
Class IIActive
Valproic Acid 5108438190
FDA UDI
Class IIActive
Elecsys CA 15-3 II 09755594190
FDA UDI
Class IIActive
ONLINE DAT Benzodiazepines II 04939417190
FDA UDI
Class IIActive
Tina-quant Cystatin C Gen.2 08105596190
FDA UDI
Class IIActive
Tinaquant 2Microglobulin 11660551216
FDA UDI
Class IIActive
cobas 6800 System 05524245001
FDA UDI
Class IIUnknown

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