FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00894175000053
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD 1201-2
Catalog number
1201-2
Device description
AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
Published
2021-08-10
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
LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFZEnzyme Linked Immunoabsorbent Assay, CytomegalovirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894175000053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000053008941750000538941750000530894175000053

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) 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
Special Storage Condition, Specify00between 2 and 8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8185913030onestep@rapidtest.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
00816870024240CMV IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024257CMV IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
00816870024288CMV IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024295CMV IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
04048474027976CMV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFZ2023-08-29
00840239027979CMV IgG ELISA DRG International IncLFZ2023-08-24
00380740181093AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
00380740181109AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
07613336193082Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-07
07613336198469Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-06
00894175000558AccuDiag™Diagnostic Automation, Inc.LFZ2021-11-29
B3507203200Gold Standard Diagnostics Is-CMV IgG ELISA Test KitGold Standard Diagnostics CorporationLFZ2020-06-03
05391516746885Trinity BiotechCLARK LABORATORIES, INC.LFZ2019-12-27
00630414588872ADVIA Centaur CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2019-02-10
00630414246635Atellica IM CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2018-11-30
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
04015630940172Elecsys CMV IgGRoche Diagnostics GmbHLFZ2017-04-21
04015630940189Elecsys CMV IgMRoche Diagnostics GmbHLFZ2017-04-17
08056771101943LIAISON® CMV IgMDIASORIN SPALFZ2016-09-24
00630414961231IMMULITE® 2000 Systems CVG CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
00630414963822IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
05391516745024Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516745031Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516743419Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516743426Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516746991Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
04015630937172Elecsys CMV IgG AssayRoche Diagnostics GmbHLFZ2016-09-20
04015630938926Elecsys CMV IgM ImmunoassayRoche Diagnostics GmbHLFZ2016-09-20