OraQuick Ebola Rapid Antigen Test

GUDID 00608337001433

Orasure Technologies, Inc.

Ebola virus antigen IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00608337001433
NIH Device Record Keyf6ffa959-f1ef-4d29-a0d4-1279ab368812
Commercial Distribution StatusIn Commercial Distribution
Brand NameOraQuick Ebola Rapid Antigen Test
Version Model Number3001-2940
Company DUNS114152184
Company NameOrasure Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337001426 [Primary]
GS100608337001433 [Package]
Contains: 00608337001426
Package: box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-03-01

Devices Manufactured by Orasure Technologies, Inc.

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00608337001433 - OraQuick Ebola Rapid Antigen Test2020-03-09
00608337001433 - OraQuick Ebola Rapid Antigen Test2020-03-09
20608337000119 - OraSure Oral Fluid Collection Device2019-03-11
00608337000863 - OraSure HIV-1 Western Blot Kit2018-09-14
20608337000065 - OraSure Quick Flu 22-Count Flu A + B Kit2018-07-06
00608337000009 - OraQuick Advance HIV 1/2 Kit Controls2018-07-06
20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test2018-07-06

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