FDA Device Establishments · JSON-LD · Markdown

ROCHE MOLECULAR SYSTEMS, INC.

FEI 2243471 · Manufacture Device in the United States for Export Only · Status: Active

FEI Number2243471
Owner / OperatorRoche Diagnostics Operations Inc. (#9039767)
Address1080 US Highway 202 South, Branchburg, NJ, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)PAB
Regulation § (21 CFR)866.3180
Proprietary namesKIT CAP-G/CTM CMV 72 TESTS CE-IVD; KIT COBAS 58/68/88 CMV DUAL 192T CE IVD; KIT COBAS 58/68/88 CMV DUAL RMC IVD

External sources

Source: openFDA. Public-domain (CC0).