FDA.reportPublic FDA data

Validate

Primary DI
00850011135402
Brand
Validate
Company
Lgc Clinical Diagnostics, Inc.
Model
510mm
Device description
Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control
Published
2022-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011135402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011135402008500111354028500111354020850011135402

GMDN Terms#

Term, Definition table
TermDefinition
Multiple human hormone IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple human hormones in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
075886031
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011135556VALIDATE1002ro2026-07-07
00850011135853Validate601ab601ro2026-07-07
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135556VALIDATELgc Clinical Diagnostics, Inc.JJY2026-07-07
00850011135853ValidateLgc Clinical Diagnostics, Inc.JJY2026-07-07
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
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15