Devices

Device Recall UltraVision Detection System, AntiRabbit, AlkPhos/BCIP/NBT (Ready to Use)

Model / Serial
Catalog number: TR-015-AB; Lot Number: RAB110810, 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
UltraVision Detection System; || Anti-Rabbit, Alk-Phos/BCIP/NBT (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 UltraVision Detection System, AntiRabbit, AlkPhos/BCIP/NBT (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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