InTray® Mueller Hinton Chocolate Agar 22-483-001

GUDID B08824834

Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.

BIO-MED DIAGNOSTICS, INC.

Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
Primary Device IDB08824834
NIH Device Record Keyd00ea085-7b13-4a76-b77a-90d43952336f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInTray® Mueller Hinton Chocolate Agar
Version Model Number2483
Catalog Number22-483-001
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB08824830 [Primary]
HIBCCB08824832 [Package]
Contains: B08824830
Package: Box [5 Units]
In Commercial Distribution
HIBCCB08824834 [Package]
Contains: B08824830
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 Number2
Public Version Date2020-02-04
Device Publish Date2019-10-16

Devices Manufactured by BIO-MED DIAGNOSTICS, INC.

B088212730010 - InTray® SAB+PVG2023-10-13 InTray SAB+PVG is for growth and observation of fungi, yeasts and dermatophytes. Inhibition is enhanced with the introduction of
B08816120 - Saline Solution (0.85%)2020-10-07 Saline Solution (0.85%) is a saline solution for viral specimens.
B08815934 - InTray DM-FungID2020-02-18 InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens w
B08824834 - InTray® Mueller Hinton Chocolate Agar2020-02-04Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
B08824834 - InTray® Mueller Hinton Chocolate Agar2020-02-04 Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative proce
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.