ANA Detect ELISA EIA-4117

GUDID 04048474041170

ANA Detect ELISA is a test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro 52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples.

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474041170
NIH Device Record Keyc44349c3-2035-435a-b8da-56e0fb98d784
Commercial Distribution StatusIn Commercial Distribution
Brand NameANA Detect ELISA
Version Model NumberEIA-4117
Catalog NumberEIA-4117
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.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
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
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
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
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
GS104048474041170 [Primary]

FDA Product Code

LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

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