4 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·August 3, 2016
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·November 28, 2012
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code KTN·June 22, 2016