FDA.reportPublic FDA data

VALIDATE

Primary DI
00850011135860
Brand
VALIDATE
Company
Lgc Clinical Diagnostics, Inc.
Model
405re
Catalog number
405re
Device description
VALIDATE High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011135860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011135860008500111358608500111358600850011135860

GMDN Terms#

Term, Definition table
TermDefinition
Troponin T/Troponin I 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 troponin T and/or troponin I in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-10 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-377-9684CDx-Info@lgcgroup.com

Regulatory Flags#

DUNS number
075886031
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
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00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956807Refractrol SP HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075957286Refractrol SP LowLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956791Refractrol SP 6.0 LowLgc Clinical Diagnostics, Inc.JJX2026-07-28
10758750035847VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-07-21
05060169690899IDS High Sensitive Estradiol Control SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
05060169691087IDS Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
05060169697218IDS High Sensitive Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
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00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
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