ACCURUN®

Primary DI
00850041090023
Brand
ACCURUN®
Company
Lgc Clinical Diagnostics, Inc.
Model
2015-0240
Published
2024-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041090023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041090023008500410900238500410900230850041090023

GMDN Terms#

Term, Definition table
TermDefinition
Multiple infectious organism/newborn TORCH screen 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 G (IgG) and/or immunoglobulin M (IgM) antibodies to organisms in a clinical specimen, as part of an antenatal or newborn infection TORCH screen. The assay is intended to detect infection by multiple organisms that include Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV), Herpes simplex virus 1 (HSV1), Herpes simplex virus 2 (HSV2), human immunodeficiency virus 1 (HIV1), measles virus and/or Treponema pallidum, and sometimes additional organisms.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850075956005AccuPlex™ Febrile Illness Control Pack2800-01442026-09-18
00850011135884VALIDATE809re2026-08-25
00850011135853Validate601ab601ab2026-07-07
00850075956777Refractrol SP Normal846532026-07-30
00850075956784Refractrol SP 9.0 High846552026-07-30
00850075956807Refractrol SP High846542026-07-30
00850075957286Refractrol SP Low846522026-07-30
00850075956791Refractrol SP 6.0 Low846792026-07-28
00850011135556VALIDATE1002ro2026-07-07
00850011135877VALIDATE808re2026-06-05
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