HDL-C/LDL-C Calibrator 990-28011

GUDID 10856626006035

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator
Primary Device ID10856626006035
NIH Device Record Keyd7632d9c-33a0-46b4-b87f-224d7286a0ff
Commercial Distribution Discontinuation2020-10-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHDL-C/LDL-C Calibrator
Version Model Number990-28011
Catalog Number990-28011
Company DUNS690598875
Company NameFUJIFILM WAKO PURE CHEMICAL CORPORATION
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856626006038 [Unit of Use]
GS110856626006035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JISCalibrator, Primary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-10-26
Device Publish Date2016-12-07

On-Brand Devices [HDL-C/LDL-C Calibrator]

10856626006035In-Vitro Diagnostic Use
04987481164550In-Vitro Diagnostic Use
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