OC-Auto

GUDID 00816917025995

OC-Auto SENSOR io Personal Use Kit for Diagnostic Laboratory Services

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Faecal occult blood IVD, reagent
Primary Device ID00816917025995
NIH Device Record Key8d031651-830c-4d9d-bbbd-3916008c2cb2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOC-Auto
Version Model NumberOCPUIO-DLS
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
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816917025995 [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 Date2023-03-08
Device Publish Date2023-02-28

On-Brand Devices [OC-Auto]

00816917024547Personal Use Kit OC-Auto, for Yale New Haven Medical
00816917024530Personal Use Kit OC-Auto, for Bronson Methodist Hospital Lab
00816917024523Personal Use Kit OC-Auto, for Middletown Medical
00816917024516Personal Use Kit OC-Auto, no mailer, for customers
00816917024486Personal Use Kit OC-Auto, for UPHT
00816917024479Personal Use Kit OC-Auto, for LASF
00816917024462Personal Use Kit OC-Auto, for LAGL
00816917024455Personal Use Kit OC-Auto, for LAMV
00816917024448Personal Use Kit OC-Auto, for Huntington Int Med Gro
00816917024424Personal Use Kit OC-Auto, for MCHC
00816917024417Personal Use Kit OC-Auto, for SLHP
00816917024400Personal Use Kit OC-Auto, Custom Kit for Virginia Physicians
00816917024394Personal Use Kit OC-Auto, for Valley Care Hlth Sys
00816917024387Personal Use Kit OC-Auto, Custom Kit for UNC
00816917024370Personal Use Kit OC-Auto, for Univ of MO
00816917024363Personal Use Kit OC-Auto, Custom Kit for Umass Memorial Hospital Med Center
00816917024356Personal Use Kit OC-Auto, Custom Kit for UM4
00816917024349Personal Use Kit OC-Auto, for Univ of Miami
00816917024332Personal Use Kit OC-Auto, Custom Kit for The Longstreet Clin
00816917024325Personal Use Kit OC-Auto, Custom Kit for St Cloud Medical
00816917024318Personal Use Kit OC-Auto, for Rockford Memorial Hosp
00816917024301Personal Use Kit OC-Auto, for Rancho Los Amigos
00816917024295Personal Use Kit OC-Auto, Custom Kit for Phy A Lab GEM
00816917024288Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH7
00816917024271Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH6
00816917024264Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH5
00816917024257Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH4
00816917024240Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH3
00816917024233Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH2
00816917024226Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH1
00816917024219Personal Use Kit OC-Auto, for Prevea Health East
00816917024202Personal Use Kit OC-Auto, Custom Kit for Path Group
00816917024196Personal Use Kit OC-Auto, for Mem Med Center
00816917024189Personal Use Kit OC-Auto, for MedLabs
00816917024172Personal Use Kit OC-Auto, for McLaren Med Ctr-Macomb
00816917024165Personal Use Kit OC-Auto, for McLaren Oakland
00816917024158Personal Use Kit OC-Auto, for McLaren Flint Med Labs
00816917024141Personal Use Kit OC-Auto, for Monroe Clinic
00816917024134Personal Use Kit OC-Auto, Custom Kit for Lovelace Health Plan
00816917024127Personal Use Kit OC-Auto, Custom Kit for W.T Evjue Clin
00816917024110Personal Use Kit OC-Auto, Custom Kit for Jyc & Mrsh E Clin
00816917024103Personal Use Kit OC-Auto, Custom Kit for LAC Itasca, IL
00816917024097Personal Use Kit OC-Auto, Custom Kit for LAC Roybal
00816917024080Personal Use Kit OC-Auto, Custom Kit for LAC El Monte
00816917024073Personal Use Kit OC-Auto, Custom Kit for Jefferson Medical Center
00816917024066Personal Use Kit OC-Auto, for Jackson Madison CtyGenHos
00816917024059Personal Use Kit OC-Auto, for Jackson Clinic
00816917024042Personal Use Kit OC-Auto, Custom Kit for HI West Mgmt Grp
00816917024035Personal Use Kit OC-Auto, for Gunderson Hlth System
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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