FDA.reportPublic FDA data

ACCURUN®

Primary DI
00816784020260
Brand
ACCURUN®
Company
Lgc Clinical Diagnostics, Inc.
Model
2015-0066
Catalog number
2015-0066
Device description
ACCURUN 106 Series 1000 HIV-1 Ag 12 x 3.5 mL
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MYZKit, Test (Donors), For Bloodborne Pathogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYZKit, Test (Donors), For Bloodborne PathogenUnknown2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9900320

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9900320

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816784020260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816784020260008167840202608167840202600816784020260

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 antigen 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 human immunodeficiency virus 1 (HIV1) antigens in a clinical specimen.

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
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
00816784020901ACCURUN® 365 Series 200 Lgc Clinical Diagnostics, Inc.MYZ2020-08-24
00816784020253ACCURUN®Lgc Clinical Diagnostics, Inc.MYZ2018-09-24
00884883006270Acrometrix WNVRNAMicrogenics CorporationMYZ2018-09-17
00884883005907AcroMetrix BB NAT WNV Negative ControlMicrogenics CorporationMYZ2017-01-25
00884883005891Acrometrix BB NAT HIV-1 POS. CTRLMicrogenics CorporationMYZ2016-09-22
00884883005921AcroMetrix BB NAT HCV Positive ControlMicrogenics CorporationMYZ2016-09-22
00884883005945AcroMetrix BB NAT Negative ControlMicrogenics CorporationMYZ2016-09-22
00847661002567VIROCLEARBIO-RAD LABORATORIES, INC.MYZ2016-09-12
00847661002574VIROCLEARBIO-RAD LABORATORIES, INC.MYZ2016-09-12
00847661002581VIROCLEARBIO-RAD LABORATORIES, INC.MYZ2016-09-12