FDA.reportPublic FDA data

"s LDL-EX ""SEIKEN"""

Primary DI
04987503562760
Brand
"s LDL-EX ""SEIKEN"""
Company
DENKA COMPANY LIMITED
Model
562760
Published
2018-06-29
Public version status
Update
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
PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction TestClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161679000s LDL-EX SEIKENDenka Seiken Co., Ltd.2017-08-18PYP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987503562760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987503562760049875035627604987503562760

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00shading
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 408-371-8819xx@xx.xx

Regulatory Flags#

DUNS number
694830238
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987503562906small dense LDL Seiken08834083190088340831902024-12-18
04987503562883small dense LDL Seiken08834059190088340591902020-10-13
04987503562890small dense LDL Seiken08834075190088340751902020-10-13
04987503562791"s LDL-EX ""SEIKEN"""5627912018-06-29
04987503562807"s LDL-EX ""SEIKEN"""5628072018-06-29
04987503563071small dense LDL Calibrator08834091190088340911902020-10-13
04987503563088small dense LDL Control Set08834105190088341051902020-10-13
04987503563002Lipid Calibrator S5630022018-06-29
04987503563026Lipid Control S-Ⅱ5630262018-06-29
04987503563019Lipid Control S-Ⅰ5630192018-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987503562906small dense LDL SeikenDENKA COMPANY LIMITEDPYP2024-12-18
04987503562883small dense LDL SeikenDENKA COMPANY LIMITEDPYP2020-10-13
04987503562890small dense LDL SeikenDENKA COMPANY LIMITEDPYP2020-10-13
04987503562791"s LDL-EX ""SEIKEN"""DENKA COMPANY LIMITEDPYP2018-06-29
04987503562807"s LDL-EX ""SEIKEN"""DENKA COMPANY LIMITEDPYP2018-06-29