FDA.reportPublic FDA data

ACCURUN®

Primary DI
00816784020444
Brand
ACCURUN®
Company
Lgc Clinical Diagnostics, Inc.
Model
2015-0088
Catalog number
2015-0088
Device description
ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K972884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972884000ACCURUN 146 CMV IGM POSITIVE CONTROLBoston Biomedica, Inc.1997-08-22LKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816784020444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816784020444008167840204448167840204440816784020444

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106267123
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011135891VALIDATE609re2026-06-02
00850011135860VALIDATE405re405re2026-04-29
00850011135747VALIDATE1004ro2026-04-24
00850075957330KOVA-Trol II Low Abnormal871302026-04-17
00850075957378KOVA-Trol III Normal with hCG873272026-04-17
00850075957385KOVA-Trol III Normal with hCG873312026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen 873322026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen 873342026-04-17
00850075957415KOVA-Trol III Normal with hCG875282026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value Assignment875332026-04-17
00850075956319Optitrol NAT TriplexNT010422026-01-30
00850075956326Optitrol NAT TriplexNT010412026-01-30
00850075956999Optitrol HEPR-2SR120552026-01-30
00850075957002Optitrol HEPR-2SR120572026-01-30
00850075957033Optitrol Mumps MSR150652026-01-30
00850075957040Optitrol Mumps MSR150672026-01-30
00850075957057Optitrol Mumps MSR150682026-01-30
00850011135846VALIDATE807re2026-01-06
00850041090139ACCURUN EBV DNA Positive Control2020-02102025-11-21
00850041090146ACCURUN BKV DNA Positive Control 2020-02092025-11-21

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
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
03573026156848VIDAS® CMV IgMBIOMERIEUX SALKQ2016-08-31