FDA.reportPublic FDA data

Solomon Commutable Quality Materials

Primary DI
00850083817039
Brand
Solomon Commutable Quality Materials
Company
Solomon Park Research Laboratories, Inc.
Model
20001LRCK
Catalog number
20001LRCK
Device description
LRC - Lipid Reference value Control Kit, 3 level Contains 3 vials,1 0.6mL vial of each:00850038317008 - Low00850083817015 - High00850083817022 - Cal&QC
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083817046PackageGS127In Commercial Distribution
00850083817039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083817046008500838170468500838170460850083817046
00850083817039008500838170398500838170390850083817039

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume1.8Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-85 Degrees Celsius-65 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
425-650-2000info@solomon.org

Regulatory Flags#

DUNS number
943785295
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083817008Solomon Commutable Quality Materials20001LRCL20001LRCL2026-04-06
00850083817015Solomon Commutable Quality Materials20001LRCH20001LRCH2026-04-06
00850083817022Solomon Commutable Quality Materials20001LRCC20001LRCC2026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727018977POINTE Chemistry Calibrator SetHORIBA INSTRUMENTS INCORPORATEDJIX2026-05-01
00850083817008Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817015Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
00850033167184Smartest Persona II Multi Blood Glucose Monitoring SystemGlobalmed Holdings, LLCJIX2024-12-02
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIX2024-04-03
00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
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00852676007780Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2020-03-28
00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
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04250317543387Serum Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543394Serum Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22