Home GUDID 00608337001433 OraQuick Ebola Rapid Antigen Test
Primary DI 00608337001433
Brand OraQuick Ebola Rapid Antigen Test
Company Orasure Technologies, Inc.
Model 3001-2940
Published 2020-03-01
Public version status New
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 QID Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QID Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00608337001433 Package GS1 25 In Commercial Distribution 00608337001426 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 00608337001433 00608337001433 608337001433 0608337001433 00608337001426 00608337001426 608337001426 0608337001426
GMDN Terms# Term, Definition table Term Definition Ebola virus antigen IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple strains of Ebola virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 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 00608337001426 OraQuick Ebola Rapid Antigen Test Orasure Technologies, Inc. QID 2020-03-01
orasure.com