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Devices
Device Recall ORASURE Barbiturates Intercept MicroPlate EIA
Model / Serial
Lot # 6654085
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to KS, and VA
Product Description
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) || Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
Manufacturer
OraSure Technologies, Inc.
1 Event
Recall of Device Recall ORASURE Barbiturates Intercept MicroPlate EIA
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Manufacturer
OraSure Technologies, Inc.
Manufacturer Address
OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
Manufacturer Parent Company (2017)
OraSure Technologies, Inc.
Source
USFDA
Language
English
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