CH50 Calibrator 997-43801

GUDID 00856626006151

In-Vitro Diagnostic Use

WAKO LIFE SCIENCES, INC.

Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent
Primary Device ID00856626006151
NIH Device Record Key54c80851-f3d0-412e-abde-e0acfc7f7fa1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCH50 Calibrator
Version Model Number997-43801
Catalog Number997-43801
Company DUNS078629716
Company NameWAKO LIFE SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower
Special Storage Condition, SpecifyBetween 0 and 0 *Store at -10 Degrees Celsius or lower

Device Identifiers

Device Issuing AgencyDevice ID
GS100856626006151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAEComplement C9, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-07

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