FOBT-CHEK

GUDID 00816917025179

Positive Control for OC-Auto SENSOR io

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Faecal occult blood IVD, control
Primary Device ID00816917025179
NIH Device Record Keye904c59a-75c9-4f90-8a67-2e9519a22a25
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOBT-CHEK
Version Model NumberOCIOQP
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 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS100816917025179 [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 Date2021-07-08
Device Publish Date2021-06-30

On-Brand Devices [FOBT-CHEK]

00816917021539Positive/Negative Controls for OC-Light and OC-Light S
00855574005520Negative Control for OC-Auto
00855574005209Positive Control for OC-Auto
00816917025308Negative Control for OC-Auto for Brazil
00816917025292Positive Control for OC-Auto for Brazil
00816917025179Positive Control for OC-Auto SENSOR io

Trademark Results [FOBT-CHEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FOBT-CHEK
FOBT-CHEK
78427292 3005144 Live/Registered
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
2004-05-28

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