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Company-Registration
1261881002
Device Listing 1261881002
Listing Summary
#
Listing key
1261881002
Premarket submission
K240197
Device
cobasĀ® liat CT/NG/MG nucleic acid test
Applicant
Roche Molecular Systems, Inc.
Product code
QEP
Decision date
2025-01-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
199742
2243471
2243471
ROCHE MOLECULAR SYSTEMS, INC.
1
N
2026-01-01
1080 US Highway 202 South Branchburg NJ US 08876
18855
9610126
3002806559
Brian Frazier
1
N
2026-01-01
9115 Hague Rd Indianapolis IN US 46256
18856
3003795116
3003795116
ROCHE DIAGNOSTICS INTERNATIONAL LTD.
1
N
2026-01-01
FORRENSTRASSE 2 ROTKREUZ Zug CH CH-6343
199771
3004141078
3004141078
ROCHE MOLECULAR SYSTEMS, INC.
1
N
2026-01-01
4300 HACIENDA DRIVE PLEASANTON CA US 94588