InTray® TSA 21-443-001

GUDID B08814434

A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique.

BIO-MED DIAGNOSTICS, INC.

Basic/simple nutrient agar culture medium IVD
Primary Device IDB08814434
NIH Device Record Key32b70c88-7938-4f90-b22c-93d5a12bd56f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInTray® TSA
Version Model Number1443
Catalog Number21-443-001
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
HIBCCB08814430 [Primary]
HIBCCB08814432 [Package]
Contains: B08814430
Package: Box [5 Units]
In Commercial Distribution
HIBCCB08814434 [Package]
Contains: B08814430
Package: Box [20 Units]
In Commercial Distribution

FDA Product Code

JSGCulture Media, Non-Selective And Non-Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2018-09-12

Devices Manufactured by BIO-MED DIAGNOSTICS, INC.

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B08810804 - InTray™ GC2019-07-18 Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
B08812634 - InTray® SAB2019-07-18 A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approx
B08815034 - InTray® BHI2019-07-18 Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, includin
B08820630 - InTray® DM 2019-07-18 An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.

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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