L-Type HDL-C (Reagent 2) 997-00201

GUDID 10856626006141

The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL)

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 ID10856626006141
NIH Device Record Key299f709a-e933-4b4d-b278-9a16b0c1e7da
Commercial Distribution Discontinuation2020-10-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameL-Type HDL-C (Reagent 2)
Version Model Number997-00201
Catalog Number997-00201
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
GS100856626006144 [Unit of Use]
GS110856626006141 [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 Date2016-11-11

On-Brand Devices [L-Type HDL-C (Reagent 2)]

10856626006141The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipopro
04987481164574The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipopro

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