FDA.reportPublic FDA data

IDG/Sanzay

Primary DI
00850053916267
Brand
IDG/Sanzay
Company
IDG/SANZAY Corporation
Model
1
Catalog number
QS01
Device description
The Multi-Analyte Chemistry calibrator is for use as a calibrator of IDG Clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures.
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070207000MULTI-ANALYTE CHEMISTRY CALIBRATORPointe Scientific, Inc.,2007-04-13JIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053916267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053916267008500539162678500539162670850053916267

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948875013
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053916212IDG/Sanzay1HCC12024-01-12
00850053916229IDG/Sanzay1HCC22024-01-12
00850053916007IDG/Sanzay1C0212023-12-18
00850053916205IDG/Sanzay1HC3012024-07-03
00850053916113IDG/Sanzay1C2432024-06-25
00850053916236IDG/Sanzay1QC012024-06-25
00850053916243IDG/Sanzay1QC022024-06-25
00850053916250IDG/Sanzay1QS31D2024-06-25
00850053916137IDG/Sanzay1C3432024-01-12
00850053916076IDG/Sanzay1C1052024-01-15
00850053916120IDG/Sanzay1C3212024-01-12
00850053916144IDG/Sanzay1C3912024-01-12
00850053916151IDG/Sanzay1C4032024-01-12
00850053916168IDG/Sanzay1C4132024-01-12
00850053916175IDG/Sanzay1C5012024-01-12
00850053916182IDG/Sanzay1HC1012024-01-12
00850053916199IDG/Sanzay1HC2012024-01-12
00850053916069IDG/Sanzay1C0952024-01-09
00850053916083IDG/Sanzay1C1232024-01-09
00850053916090IDG/Sanzay1C1532024-01-09

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Primary DI, Brand, Company table
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00850083817015Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817039Solomon 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
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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
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