FDA.reportPublic FDA data

ENZYMATIC CREATININE Assay

Primary DI
00628063400393
Brand
ENZYMATIC CREATININE Assay
Company
SEKISUI DIAGNOSTICS, LLC
Model
265-30
Catalog number
265-30
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
JFYENZYMATIC METHOD, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070383000ENZYMATIC CREATININE ASSAY (265 SERIES)Diagnostic Chemicals , Ltd.2007-06-22JFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400393006280634003936280634003930628063400393

GMDN Terms#

Term, Definition table
TermDefinition
Creatinine IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of creatinine in a clinical specimen, using an enzyme spectrophotometry method.

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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