FDA-Device2013-03-20Class II
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.
Innominata Dba Genbio
Hazard
Multiple incidents of low-reacting assay plates.
Sold states
Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
Affected count
195
Manufactured in
15222 Avenue Of Science Ste A, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2013Don't want to check this manually?
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