FDA.reportPublic FDA data

N-geneous LDL Cholesterol Calibrator

Primary DI
00628063400713
Brand
N-geneous LDL Cholesterol Calibrator
Company
SEKISUI DIAGNOSTICS, LLC
Model
80-4610-02
Catalog number
80-4610-02
Published
2016-09-16
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
JISCALIBRATOR, PRIMARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400713PrimaryGS10
10628063400710Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400713006280634007136280634007130628063400713
1062806340071010628063400710

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
3
Kit
true
Lot or batch
true
Expiration date on label
true

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50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

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Primary DI, Brand, Company table
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