FDA.reportPublic FDA data

MICROALBUMIN Calibrators

Primary DI
00628063400836
Brand
MICROALBUMIN Calibrators
Company
SEKISUI DIAGNOSTICS, LLC
Model
SE-252
Catalog number
SE-252
Published
2016-09-20
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
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042243000MICROALBUMIN MULTI-CALIBRATOR SETDiagnostic Chemicals , Ltd.2004-10-04JIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400836006280634008366280634008360628063400836

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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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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