FDA.reportPublic FDA data

Specimen mailer kit

Definition
A collection of non-sterile items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. It is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.
GUDID devices
14
Last updated
2020-02-18 20:21:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
50885380177017Aero-MedAero-Med, Ltd.CA267752020-02-04
50885380175846Aero-MedAero-Med, Ltd.CA255752019-11-06
50192253021996CARDINAL HEALTHAero-Med, Ltd.CA72262019-11-05
50885380170810Aero-MedAero-Med, Ltd.CA238752019-06-13
50885380173262Aero-MedAero-Med, Ltd.CA217502019-06-07
00856820008005IBSchekCOMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.IVD-1-Chek2018-05-17
00627595000019Oragene DxDNA Genotek IncOGD-5002016-09-08
00627595000026Oragene DxDNA Genotek IncOGD-500.0012016-09-08
00627595000132Oragene DxDNA Genotek IncOGD-5102016-09-08
00627595000224Oragene DxDNA Genotek IncOGD-5752016-09-08
00627595000248Oragene DxDNA Genotek IncOGD-6002016-09-09
00627595000255Oragene DxDNA Genotek IncOGD-6102016-09-09
00627595000262Oragene DxDNA Genotek IncOGD-6752016-09-09
00627595000309ORAcollect DxDNA Genotek IncOCD-1002016-09-10