FDA.reportPublic FDA data

ACCURUN®

Primary DI
00816784020697
Brand
ACCURUN®
Company
Lgc Clinical Diagnostics, Inc.
Model
2025-0068
Catalog number
2025-0068
Device description
ACCURUN 342 Series 700 CT/NG 10 x 1.0 mL
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DGQWhole Blood Plasma, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DGQWhole Blood Plasma, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816784020697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816784020697008167840206978167840206970816784020697

GMDN Terms#

Term, Definition table
TermDefinition
Multiple sexually transmitted pathogen nucleic acid 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 nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010518175AQCFertility Solutions, Inc.DGQ2023-10-30
08600105181752AQCFertility Solutions, Inc.DGQ2023-09-15
00816784020925ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mLLgc Clinical Diagnostics, Inc.DGQ2021-08-18
00816784020932ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mLLgc Clinical Diagnostics, Inc.DGQ2021-08-18
00816784020130ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020147ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020154ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020161ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020178ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020185ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020192ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020208ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020239ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020246ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020277ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020284ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020345ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020352ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020369ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020406ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020420ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020482ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020499ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020635ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020642ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020659ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020666ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020673ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020680ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020703ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24