Devices

Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit

Model / Serial
Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
Product Description
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
Manufacturer
Innominata Dba Genbio
1 Event
- Recall of Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit

Manufacturer

Innominata Dba Genbio

Manufacturer Address
Innominata Dba Genbio, 15222 Avenue Of Science Ste A, San Diego CA 92128-3422
Manufacturer Parent Company (2017)
Innominata
Source
USFDA

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