OC-Auto

GUDID 00816917021607

Personal Use Kit OC-Auto, for Jacksonville, FL

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Faecal occult blood IVD, reagent
Primary Device ID00816917021607
NIH Device Record Keyd599eff9-62db-4349-9a79-9c075fe17a76
Commercial Distribution StatusIn Commercial Distribution
Brand NameOC-Auto
Version Model NumberOCPU-VA1 213250
Company DUNS078413594
Company NamePOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
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 Usetrue
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

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816917021607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOXAutomated Occult Blood Analyzer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-24
Device Publish Date2018-09-23

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00816917024103Personal Use Kit OC-Auto, Custom Kit for LAC Itasca, IL
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00816917024059Personal Use Kit OC-Auto, for Jackson Clinic
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00816917024028Personal Use Kit OC-Auto, for Dynacare Lab

Trademark Results [OC-Auto]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OC-AUTO
OC-AUTO
76597320 3022594 Live/Registered
Eiken Kagaku Kabushiki Kaisha
2004-06-15

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