QuikCoag Calcium Chloride 0.02M

GUDID 10627944000094

Biomedica Diagnostics Inc

Calcium chloride coagulation reagent IVD
Primary Device ID10627944000094
NIH Device Record Keycf39613f-32fc-49ba-87be-a9fde53015f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuikCoag Calcium Chloride 0.02M
Version Model Number4 mL
Company DUNS200152713
Company NameBiomedica Diagnostics Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100627944000097 [Primary]
GS110627944000094 [Package]
Contains: 00627944000097
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GFOActivated Partial Thromboplastin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2016-09-22

Devices Manufactured by Biomedica Diagnostics Inc

00627944000011 - QuikCoag PT-HS2020-02-24
00627944000028 - QuikCoag PT-HS2020-02-24
10627944000032 - QuikCoag PT-HS2020-02-24
00627944000042 - QuikCoag APTT-EA2020-02-24
00627944000059 - QuikCoag APTT-EA2020-02-24
10627944000063 - QuikCoag Control Level 1 Normal2020-02-24
10627944000070 - QuikCoag Control Level 2 Low Abnormal2020-02-24
10627944000087 - QuikCoag Control Level 3 High Abnormal2020-02-24

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