FDA.reportPublic FDA data

Refractrol SP High

Primary DI
00850075956807
Brand
Refractrol SP High
Company
Lgc Clinical Diagnostics, Inc.
Model
84654
Device description
Refractrol™ SP is a reference control consisting of bovine serum albumin in a synthetic matrix. It is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol SP controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
Published
2026-07-30
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

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
00850075956807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075956807008500759568078500759568070850075956807

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
106267123
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00850075956777Refractrol SP Normal846532026-07-30
00850075956784Refractrol SP 9.0 High846552026-07-30
00850075957286Refractrol SP Low846522026-07-30
00850075956791Refractrol SP 6.0 Low846792026-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 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
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
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
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
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
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13