OraSure HIV-1 Western Blot Kit

GUDID 00608337000863

Orasure Technologies, Inc.

HIV1 antibody IVD, kit, immunoblot
Primary Device ID00608337000863
NIH Device Record Keye226451e-63c4-4290-9b3a-05bee4d103c6
Commercial Distribution Discontinuation2018-08-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOraSure HIV-1 Western Blot Kit
Version Model Number501-0000
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 Kittrue
Device Combination Productfalse
Single Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337000863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVZSystem,Test,Home,Hiv-1

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-14
Device Publish Date2014-09-05

Devices Manufactured by Orasure Technologies, Inc.

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00608337000863 - OraSure HIV-1 Western Blot Kit2018-09-14
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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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