L-Type HDL-C Reagent 1 997-72591

GUDID 10856626006196

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 ID10856626006196
NIH Device Record Key184f9652-784e-4c65-922a-7c7343c2150d
Commercial Distribution Discontinuation2020-10-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameL-Type HDL-C Reagent 1
Version Model Number997-72591
Catalog Number997-72591
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-10C. Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100856626006199 [Unit of Use]
GS110856626006196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBRLdl & Vldl Precipitation, Hdl

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 Date2016-11-23

On-Brand Devices [L-Type HDL-C Reagent 1]

10856626006196In-Vitro Diagnostic Use
04987481164581In-Vitro Diagnostic Use
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