Devices

GE Healthcare/PAA Healthcare

Model / Serial
510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
Product Description
Various types of Fetal Bovine Serum || Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Manufacturer
Paa Laboratories Inc
1 Event
- Recall of GE Healthcare/PAA Healthcare

Manufacturer

Paa Laboratories Inc

Manufacturer Address
Paa Laboratories Inc, 145 Bethridge Road, Etobicoke Canada Ontario
Manufacturer Parent Company (2017)
Paa Laboratories Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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