FDA.reportPublic FDA data

VALIDATE

Primary DI
00850011135891
Brand
VALIDATE
Company
Lgc Clinical Diagnostics, Inc.
Model
609re
Device description
VALIDATE PRO-C3 Calibration Verification / Linearity Test Kit
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00850011135891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011135891008500111358918500111358910850011135891

GMDN Terms#

Term, Definition table
TermDefinition
Procollagen type III N-terminal propeptide (PIIINP) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procollagen type III N-terminal propeptide (PIIINP) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-207-892-1300CDx-Info@lgcgroup.com

Regulatory Flags#

DUNS number
075886031
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850041090146ACCURUN BKV DNA Positive Control 2020-02092025-11-21
00850075956838Optitrol Blue SR110112025-10-30

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Primary DI, Brand, Company table
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07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
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07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008413TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21