SeraQuest Q01-230

GUDID 00850487007463

Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)

QUEST INTERNATIONAL, INC.

Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850487007463
NIH Device Record Key85c078b5-8641-4f70-b629-33d0b673e929
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeraQuest
Version Model NumberAnti-Sm
Catalog NumberQ01-230
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
GS100850487007463 [Primary]

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)
00850487007463Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
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00850487007401Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
00850487007395Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
00850487007388Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
00850487007371Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
00850487007364Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immun
00850487007357Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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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