Lipid Calibrator S

GUDID 04987503563002

DENKA SEIKEN CO., LTD.

Low density lipoprotein (LDL) cholesterol IVD, calibrator
Primary Device ID04987503563002
NIH Device Record Key75a87d4f-816d-480d-8082-b2288f950a48
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipid Calibrator S
Version Model Number563002
Company DUNS694830238
Company NameDENKA SEIKEN CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 408-371-8819
Emailxx@xx.xx
Phone+1 408-371-8819
Emailxx@xx.xx
Phone+1 408-371-8819
Emailxx@xx.xx
Phone+1 408-371-8819
Emailxx@xx.xx
Phone+1 408-371-8819
Emailxx@xx.xx
Phone+1 408-371-8819
Emailxx@xx.xx
Phone+1 408-371-8819
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *shading
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987503563002 [Primary]

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-30
Device Publish Date2018-06-29

Devices Manufactured by DENKA SEIKEN CO., LTD.

04987503562760 - s LDL-EX "SEIKEN"2019-10-21
04987503562791 - s LDL-EX "SEIKEN"2019-10-21
04987503562807 - s LDL-EX "SEIKEN"2019-10-21
04987503563002 - Lipid Calibrator S2018-07-30
04987503563002 - Lipid Calibrator S2018-07-30
04987503563019 - Lipid Control S-Ⅰ2018-07-30
04987503563026 - Lipid Control S-Ⅱ2018-07-30

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