FDA.reportPublic FDA data

Measles Virus IgG Avidity ELISA

Primary DI
00840239059673
Brand
Measles Virus IgG Avidity ELISA
Company
DRG International Inc
Model
EIA-5967
Catalog number
EIA-5967
Device description
The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past infection.
Published
2023-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239059673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239059673008402390596738402390596730840239059673

GMDN Terms#

Term, Definition table
TermDefinition
Measles virus immunoglobulin A (IgA)/IgG/IgM 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 immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Measles virus 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

Contacts#

Phone, Email table
PhoneEmail
1 973-564-7555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24
00840239035653Anti-dsDNA IgA ELISAEIA-3565EIA-35652023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ENTIMEAG03300NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
ENTIMEAG0330NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
08033891322434CHORUS MEASLES IgGDIESSE DIAGNOSTICA SENESE SPALJB2024-01-22
04048474059670Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2023-09-01
00850049545396AccuDiag ™Diagnostic Automation, Inc.LJB2023-06-14
00847865010764Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJB2023-01-22
00404847459678Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2021-06-07
B3507205200Gold Standard Diagnostics Is-Measles IgG ELISA Test KitGold Standard Diagnostics CorporationLJB2020-05-20
05391516743631Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
05391516747127Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
03573026064532VIDAS® Measles IgGBIOMERIEUX SALJB2019-08-30
04048474038446Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00404847438444Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00840239038449Measles Virus IgG ELISADRG International IncLJB2019-03-20
04049016027973Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
04049016083276Avidity: Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
00817273020303DiamedixDIAMEDIX CORPORATIONLJB2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
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