L-Type HDL-C Reagent 2 993-72691

GUDID 04987481164598

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 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 ID04987481164598
NIH Device Record Key06d95a0e-7ba8-4dac-88a5-86581681f2a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameL-Type HDL-C Reagent 2
Version Model Number993-72691
Catalog Number993-72691
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

Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987481164598 [Unit of Use]
GS110856626006097 [Previous]
GS114987481164595 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23

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

10856626006097In-Vitro Diagnostic Use
04987481164598In-Vitro Diagnostic Use
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