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 ID: B08824834
• NIH Device Record Key: d00ea085-7b13-4a76-b77a-90d43952336f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTray® Mueller Hinton Chocolate Agar
• Version Model Number: 2483
• Catalog Number: 22-483-001
• Company DUNS: 605213545
• Company Name: BIO-MED DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B08824830 [Primary]
HIBCC	B08824832 [Package]; Contains: B08824830; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B08824834 [Package]; Contains: B08824830; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• JSG: Culture Media, Non-Selective And Non-Differential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-04
• Device Publish Date: 2019-10-16

Devices Manufactured by BIO-MED DIAGNOSTICS, INC.

• B088212730010 - InTray® SAB+PVG: 2023-10-13 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-FungID: 2020-02-18 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 Agar: 2020-02-04Mueller 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 Agar: 2020-02-04 Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative proce
• B08810804 - InTray™ GC: 2019-07-18 Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
• B08812634 - InTray® SAB: 2019-07-18 A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approx
• B08815034 - InTray® BHI: 2019-07-18 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.