FDA.reportPublic FDA data

QMedix™

Primary DI
00850054026019
Brand
QMedix™
Company
Diagnostic Automation, Inc.
Model
DACD1301-1
Catalog number
1301-1
Device description
QMedix™ Rubella IgG ELISAThis test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OPLMultiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPLMultiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster VirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054026019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054026019008500540260198500540260190850054026019

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
8185913030Onestep@rapidest.com

Regulatory Flags#

DUNS number
878252071
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
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B347VP5938800001Vanity PlanetLED TECHNOLOGIES INCOPL2024-03-13
00894175000039AccuDiag ™ Diagnostic Automation, Inc.OPL2021-08-10
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.OPL2016-09-12