FDA.reportPublic FDA data

ReQuest

Primary DI
00850487007050
Brand
ReQuest
Company
QUEST INTERNATIONAL, INC.
Model
Sm/RNP
Catalog number
Q01-240
Device description
Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKPAnti-Sm Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKPAnti-Sm Antibody, Antigen And ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850487007050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007050008504870070508504870070500850487007050

GMDN Terms#

Term, Definition table
TermDefinition
Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to Sm/RNP antigen complex (anti-Sm/RNP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
883350811
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850487007302ReQuest ANA ScreenQ01-310H2016-08-31
00850487007425SeraQuest ANA ScreenQ01-310H2016-08-31
00850487007234ReQuest Anti-TPO2016-08-31
00850487007500SeraQuest Anti-TPO2016-08-31
00850487007173ReQuest EB VCA MQ01-4802016-08-31
00850487007180ReQuestEB VCA GQ01-4702016-08-31
00850487007371SeraQuest EB VCA GQ01-4702016-08-31
00850487007418SeraQuest EB VCA MQ01-4802016-08-31
00850487007005ReQuest Anti-SSAQ01-2502016-08-31
00850487007012ReQuestVZV GQ01-1802016-08-31
00850487007029ReQuest TOXO MQ01-1302016-08-31
00850487007036ReQuest TOXO GQ01-1202016-08-31
00850487007043ReQuest Syphilis GQ01-5802016-08-31
00850487007067ReQuest RUB MQ01-1102016-08-31
00850487007074ReQuest RUB GQ01-1002016-08-31
00850487007081ReQuest Mumps MQ01-200M2016-08-31
00850487007098ReQuest MUMPS GQ01-2002016-08-31
00850487007104ReQuest MEAS MQ01-190M2016-08-31
00850487007111ReQuestMEAS GQ01-1902016-08-31
00850487007128ReQuest HSV Type 2 GQ01-4202016-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKP2023-12-14
07333066021485EliA SmDP-S WellPhadia ABLKP2021-07-20
07333066017709EliA SmDP-S WellPhadia ABLKP2021-07-20
00816879020311Autostat II Anti-SmHYCOR BIOMEDICAL LLCLKP2016-09-26
04049016027027Anti-Sm ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016083139EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016084785EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
07333066014838EliA SmDP WellPhadia ABLKP2016-09-23
07333066010885EliA SmDP WellPhadia ABLKP2016-09-23
00847661000150LiquichekBIO-RAD LABORATORIES, INC.LKP2016-09-12
00847817022449Autoimmune EIABIO-RAD LABORATORIES, INC.LKP2016-09-12
08426950595533QUANTA Flash® Sm ReagentsINOVA DIAGNOSTICS, INC.LKP2016-08-31
00850487007265ReQuestQUEST INTERNATIONAL, INC.LKP2016-08-31
00850487007593SeraQuestQUEST INTERNATIONAL, INC.LKP2016-08-31
07340058410028DIASTAT anti-Sm/RNPSvar Life Science ABLKP2016-08-12
07340058410059DIASTST anti-SmSvar Life Science ABLKP2016-08-12