Devices

Device Recall Streptavidin Alkaline Phosphatase (Ready to Use)

Model / Serial
Catalog number: TS-060-AP; Lot Number: SAP101207, Exp 6/2012; Lot Number: SAP110216, Exp 2/2013. Catalog number: TS-125-AP; Lot Number: SAP110106, Exp. 1/2013; Lot Number: SAP110405, Exp 10/2012.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
Product Description
Streptavidin Alkaline Phosphatase (Ready to Use) || Manufactured by: Lab Vision Corporation || 46360 Fremont Blvd, Fremont, CA 94538 || Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
Manufacturer
Lab Vision Corporation
1 Event
- Recall of Device Recall Streptavidin Alkaline Phosphatase (Ready to Use)

Manufacturer

Lab Vision Corporation

Manufacturer Address
Lab Vision Corporation, 46360 Fremont Blvd, Fremont CA 94538-6406
Source
USFDA

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