FDA.reportPublic FDA data

small dense LDL Seiken

Primary DI
04987503562906
Brand
small dense LDL Seiken
Company
DENKA COMPANY LIMITED
Model
08834083190
Catalog number
08834083190
Published
2024-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04987503562906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987503562906049875035629064987503562906

GMDN Terms#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987503562883small dense LDL Seiken08834059190088340591902020-10-13
04987503562890small dense LDL Seiken08834075190088340751902020-10-13
04987503562760"s LDL-EX ""SEIKEN"""5627602018-06-29
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
04987503562883small dense LDL SeikenDENKA COMPANY LIMITEDPYP2020-10-13
04987503562890small dense LDL SeikenDENKA COMPANY LIMITEDPYP2020-10-13
04987503562760"s LDL-EX ""SEIKEN"""DENKA COMPANY LIMITEDPYP2018-06-29
04987503562791"s LDL-EX ""SEIKEN"""DENKA COMPANY LIMITEDPYP2018-06-29
04987503562807"s LDL-EX ""SEIKEN"""DENKA COMPANY LIMITEDPYP2018-06-29