FDA.reportPublic FDA data

VIDAS® CMV IgM

Primary DI
03573026156848
Brand
VIDAS® CMV IgM
Company
BIOMERIEUX SA
Model
30205-01
Device description
VIDAS ® CMV IgM (CMVM) assay is an automated qualitative IA intended for use on VIDAS family instrument for detection of anti - CMV IgM antibodies in human serum.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LKQAntibody Igm,If, Cytomegalovirus Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKQAntibody Igm,If, Cytomegalovirus VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933549000VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.1994-08-02LKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026156848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026156848035730261568483573026156848

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin M (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 M (IgM) antibodies to cytomegalovirus (CMV) 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

Regulatory Flags#

DUNS number
276816717
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
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2017-08-05
00816784020444ACCURUN®Lgc Clinical Diagnostics, Inc.LKQ2016-09-24
00630414985718IMMULITE®/IMMULITE® 1000 Systems CMV IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLKQ2016-09-24
00630414985725IMMULITE® 2000 Systems CMM CMV IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLKQ2016-09-24
00847865001175BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2016-09-12
00847865003179BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2016-09-12
00847865003186BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2016-09-12
00847865011006BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2016-09-12
00847865012577BioPlex 2200BIO-RAD LABORATORIES, INC.LKQ2016-09-12