Devices

Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH

Model / Serial
US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
Product Description
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B || US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) || OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) || Product Usage: || ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Manufacturer
Siemens Healthcare Diagnostics, Inc
1 Event
- Recall of Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH

Manufacturer

Siemens Healthcare Diagnostics, Inc

Manufacturer Address
Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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