73 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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iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·October 20, 2015
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015