SeraQuest Q01-490

GUDID 00850487007524

Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

QUEST INTERNATIONAL, INC.

Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850487007524
NIH Device Record Key0140c432-fc73-494d-979a-e01092ce8294
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeraQuest
Version Model NumberEBV-EA G
Catalog NumberQ01-490
Company DUNS883350811
Company NameQUEST INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850487007524 [Primary]

FDA Product Code

LSEEpstein-Barr Virus, Other

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-31

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00850487007470SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
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00850487007395Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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00850487007340Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
00850487007333Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoass
00850487007326Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
00850487007319Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trademark Results [SeraQuest]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SERAQUEST
SERAQUEST
78879231 3215661 Live/Registered
AWARENESS TECHNOLOGY, INCORPORATED
2006-05-09
SERAQUEST
SERAQUEST
74646211 2044578 Dead/Cancelled
QUEST INTERNATIONAL, INC.
1995-03-13

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