Devices

VARIANT Sickle Cell Short Program

Model / Serial
Catalog number 270-0500, lot numbers 70000349, 70000353, both with expiration dates of 6/30/2011, which contains ROM Card Lot # LA82418 (Catalog # 270-0507). Rom Card is included in kit Lot number 70000349 and 70000353.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.
Product Description
The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of VARIANT Sickle Cell Short Program

Manufacturer

Bio-Rad Laboratories Inc

Manufacturer Address
Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
Source
USFDA

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