InTray® COLOREX Screen 21-103-001

GUDID B08811034

For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.

BIO-MED DIAGNOSTICS, INC.

Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Primary Device IDB08811034
NIH Device Record Key26a11ca3-db34-4564-8a57-a5058f8a7ee6
Commercial Distribution StatusIn Commercial Distribution
Brand NameInTray® COLOREX Screen
Version Model Number1103
Catalog Number21-103-001
Company DUNS605213545
Company NameBIO-MED DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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
HIBCCB08811030 [Primary]
HIBCCB08811032 [Package]
Contains: B08811030
Package: Box [5 Units]
In Commercial Distribution
HIBCCB08811034 [Package]
Contains: B08811030
Package: Box [20 Units]
In Commercial Distribution

FDA Product Code

JSICulture Media, Selective And Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-13

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Trademark Results [InTray]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTRAY
INTRAY
87218428 5214088 Live/Registered
Bio-Med Diagnostics, Inc.
2016-10-27
INTRAY
INTRAY
74108000 1796795 Dead/Cancelled
CODA INCORPORATED
1990-10-19

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