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Manufacturers
BioCheck Inc
Manufacturer Address
BioCheck Inc, 323 Vintage Park Dr, Foster City CA 94404-1186
Manufacturer Parent Company (2017)
Origene Technologies Inc
Source
USFDA
18 Events
Recall of Device Recall Myeloperoxidase (MPO) ELISA kit
Recall of Device Recall CKMB ELISA kit
Recall of Device Recall HSV2 IgG ELISA kit
Recall of Device Recall HSV1 IgG ELISA kit
Recall of Device Recall CVM IgG ELISA kit
Recall of Device Recall Toxoplasma IgG ELISA kit
Recall of Device Recall Rubella IgG ELISA kit
Recall of Device Recall H pylori IgG ELISA kit
Recall of Device Recall Visual hCG ELISA kit
Recall of Device Recall Free betahCG ELISA kit
Recall of Device Recall Free PSA ELISA Kit
Recall of Device Recall PSA ELISA Kit
Recall of Device Recall CA199 ELISA Kit
Recall of Device Recall CA153 ELISA Kit.
Recall of Device Recall CA125 ELISA Kit
Recall of Device Recall CEA ELISA Kit
Recall of Device Recall AFP ELISA Kit
Recall of Device Recall Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST KIT
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18 devices in the database
Device Recall Myeloperoxidase (MPO) ELISA kit
Model / Serial
Catalog number: BC-1129: RN-34227 07-2011 RN-35675 04-2011 RN-37126 06-2011.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
Myeloperoxidase (MPO) ELISA kit ; || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
Device Recall CKMB ELISA kit
Model / Serial
Catalog number: BC-1121: RN-33897 04-2010 RN-34288 04-2010 RN-35945 11-2010 RN-36594 01-2011 RN-38211 07-2011 RN-39307 07-2011 RN-39618 07-2011 RN-40219 01-2012 RN-41069 01-2012.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
CK-MB ELISA kit ; || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
Device Recall HSV2 IgG ELISA kit
Model / Serial
Catalog number: BC-1097: RN-34184 02-2010 RN-34539 05-2010 RN-34865 05-2010 RN-35243 09-2010 RN-35671 10-2010 RN-36426 12-2010 RN-37081 02-2011 RN-38186 03-2011 RN-38841 07-2011 RN-39120 08-2011 RN-39367 09-2011 RN-39551 10-2011 RN-39551A 10-2011 RN-40115 12-2011 RN-40188 01-2012 RN-40188A 01-2012 RN-40407 02-2012 RN-40407A 02-2012 RN-40955 02-2012 RN-41080 04-2012 RN-41129 02-2012 RN-41131 02-2012 RN-41132 05-2012 RN-41413 02-2012; Catalog number BC-1099: RN-33991 02-2010 RN-34549 04-2010 RN-34714 03-2012 RN-34719 03-2012 RN-34876 07-2010 RN-35141 08-2010 RN-35453 07-2010 RN-35642 10-2010 RN-35650 10-2010 RN-35891 11-2010 RN-36061 12-2010 RN-36062 11-2010 RN-36345 12-2010 RN-36408 12-2010 RN-36686 01-2011 RN-37383 03-2011 RN-37457 12-2010 RN-37535 12-2010 RN-37536 01-2011 RN-37537 03-2011 RN-37607 03-2011 RN-37817 03-2011 RN-37985 05-2011 RN-37986 05-2011 RN-38289 06-2011 RN-39196 05-2011 RN-39610 10-2011 RN-40520 10-2011 RN-40520A 10-2011 RN-40734 11-2011 RN-41084 04-2012 RN-41198 03-2012 RN-41285 01-2012 RN-41315 01-2012.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
HSV-2 IgG ELISA kit ; || HSV-2 IgM ELISA kit; || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
Device Recall HSV1 IgG ELISA kit
Model / Serial
Catalog number: BC-1093: RN-33786 03-2010 RN-33956 03-2010 RN-34538 03-2010 RN-35037 08-2010 RN-35242 09-2010 RN-36114 12-2010 RN-37937 03-2011 RN-38809 07-2011 RN-38839 06-2011 RN-39279 09-2011 RN-40515 02-2012 RN-40515A 02-2012 N-40833 02-2012 RN-40835 02-2012 RN-41271 02-2012 RN-41301 02-2012 RN-41357 02-2012; Catalog number BC-1095: RN-33990 04-2010 RN-34548 02-2010 RN-34904 04-2010 RN-35427 09-2010 RN-35807 10-2010 RN-35889 10-2010 RN-37713 03-2011 RN-38218 04-2011 RN-38875 07-2011 RN-39471 10-2011 RN-40226 10-2011 RN-40226A 10-2011 RN-40516 03-2012 RN-40942 03-2012 RN-41214 03-2012.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
HSV-1 IgG ELISA kit ; || HSV-1 IgM ELISA kit; || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
Device Recall CVM IgG ELISA kit
Model / Serial
Catalog number: BC-1089: RN-34043 02-2010 RN-34418 02-2010 RN-34795 07-2010 RN-34863 05-2010 RN-35253 08-2010 RN-35444 09-2010 RN-35908 11-2010 RN-36344 11-2010 RN-36366 12-2010 RN-36834 02-2011 RN-37257 03-2011 RN-37488 04-2011 RN-37910 05-2011 RN-38810 06-2011 RN-39366 06-2011 RN-39646 10-2011 RN-39646A 10-2011 RN-40690A 03-2012 RN-40690 03-2012 RN-40922 04-2012 RN-40114 12-2011 RN-40114A 12-2011 RN-40831 03-2012 RN-41340 04-201; Catalog number BC-1091: RN-33978 04-2010 RN-34259 05-2010 RN-34434 05-2010 RN-34588 04-2010 RN-34645 07-2010 RN-34649 07-2010 RN-35027 07-2010 RN-35028 07-2010 RN-35034 08-2010 RN-35140 07-2010 RN-35220 07-2010 RN-35308 09-2010 RN-35373 09-2010 RN-35621 09-2010 RN-35389 09-2010 RN-35520 09-2010 RN-35808 10-2010 RN-35965 11-2010 RN-35966 11-2010 RN-35967 11-2010 RN-35986 11-2010 RN-36113 12-2010 RN-36367 12-2010 RN-36481 01-2011 RN-36835 02-2011 RN-36893 02-2011 RN-37130 02-2011 RN-37319 03-2011 RN-37434 02-2011 RN-37556 03-2011 RN-37856 02-2011 RN-37912 03-2011 RN-37911 03-2011 RN-37913 03-2011 RN-37577 03-2011 RN-38076 03-2011 RN-38312 07-2011 RN-38836 05-2011 RN-38837 06-2011 RN-39036 08-2011 RN-39189 09-2011 RN-39550 10-2011 RN-39550A 10-2011 RN-39736 11-2011 RN-39843 11-2011 RN-39843A 11-2011 RN-39953 01-2012 RN-40187 01-2012 RN-40386 01-2012 RN-40725 01-2012 RN-40773 02-2013 RN-40943 02-2012 RN-40944 02-2012 RN-41319 02-2012 RN-41356 02-2012.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
CVM IgG ELISA kit ; || CVM IgM ELISA kit || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
13 more
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