Home GUDID 20608337000102 OraSure HIV-1 Oral Specimen Collection Device
Primary DI 20608337000102
Brand OraSure HIV-1 Oral Specimen Collection Device
Company Orasure Technologies, Inc.
Model HIV-1 Oral Specimen Collection Device
Published 2014-09-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MVZ System,Test,Home,Hiv-1
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MVZ System, Test, Home, Hiv-1 Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10608337000105 Package GS1 50 In Commercial Distribution 20608337000102 Package GS1 500 In Commercial Distribution 00608337000108 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10608337000105 10608337000105 20608337000102 20608337000102 00608337000108 00608337000108 608337000108 0608337000108
GMDN Terms# Term, Definition table Term Definition Oral specimen transport medium collection kit A collection of non-sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the mouth, for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], sometimes sterile, and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 18 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 114152184 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M769HIVSTANDARD211 HIV-1 Standard Test System Home Access Health Corporation MVZ 2015-09-03 M769HIVEXPRESS201 Express HIV-1 Test System Home Access Health Corporation MVZ 2015-09-03 00608337000108 OraSure HIV-1 Oral Specimen Collection Device Orasure Technologies, Inc. MVZ 2014-09-05 00608337000863 OraSure HIV-1 Western Blot Kit Orasure Technologies, Inc. MVZ 2014-09-05
orasure.com