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Devices
cobas 4800
Model / Serial
Material Number 05200881001 - all lot/serial numbers.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
cobas¿ 4800 system z480 instrument. || Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Manufacturer
Roche Molecular Systems, Inc.
1 Event
Recall of cobas 4800
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Manufacturer
Roche Molecular Systems, Inc.
Manufacturer Address
Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
25 devices with a similar name
Learn more about the data
here
Roche Cobas 4800 system
Model / Serial
Model: , Affected: Software version V1.1.x
Manufacturer
manufacturer #1479
Roche Cobas 4800
Model / Serial
Model: , Affected: cobas HBV Test for use on the cobas 4800 system (06979564190)
Manufacturer
Roche Diagnostics GmbH
cobas 4800 HPV Amplification/Detection Kit
Model / Serial
Model: , Affected: Lot numbers X10763, X09600, X13438, Y00444
Manufacturer
Roche SAS
cobas hiv-1 test for use on the cobas 4800 system; cobas hbv test for use on the cobas 4800 system
Model / Serial
Product Description
ivd
Manufacturer
ROCHE DIAGNOSTICS
Reagent Kits for the modular cobas 4800 system
Model / Serial
Manufacturer
Rosh Diagnostics GmbH
20 more
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