FDA.reportPublic FDA data

InTray® Mueller Hinton Chocolate Agar

Primary DI
B08824830
Brand
InTray® Mueller Hinton Chocolate Agar
Company
BIO-MED DIAGNOSTICS, INC.
Model
2483
Catalog number
22-483-001
Device description
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.
Published
2019-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B08824832PackageHIBCC5In Commercial Distribution
B08824834PackageHIBCC20In Commercial Distribution
B08824830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mueller-Hinton agar antimicrobial susceptibility culture medium IVDA non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.

Regulatory Flags#

DUNS number
605213545
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B088212730010InTray® SAB+PVG21272023-10-05
B08816120Saline Solution (0.85%)161211-612-0012020-09-29
B08816020VTM-C19 Transit Tube160211-602-0012020-10-05
B08815930InTray DM-FungID159321-593-0012020-02-10
B08815934InTray DM-FungID159321-593-0012020-02-10
B08824834InTray® Mueller Hinton Chocolate Agar248322-483-0012019-10-16
B08810800InTray™ GC108010-80002016-09-21
B08812630InTray® SAB126321-263-0012018-09-12
B08815030InTray® BHI150321-503-0012018-09-12
B08810804InTray™ GC108010-80002016-09-21
B08812634InTray® SAB126321-263-0012018-09-12
B08815034InTray® BHI150321-503-0012018-09-12
B08820630InTray® DM 206322-063-0002018-09-13
B08814430InTray® TSA144321-443-0012018-09-12
B08814434InTray® TSA144321-443-0012018-09-12
B08810310InPouch® TV103121-031-0012018-08-20
B08810510InPouch® TVC Subculture105121-051-0012018-09-12
B08811030InTray® COLOREX Screen110321-103-0012018-09-13
B08811130InTray® COLOREX Yeast111321-113-0012018-09-13
B08812230InTray® COLOREX Salmonella122321-223-0012018-09-12

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Primary DI, Brand, Company table
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B645T0246EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
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B6454P145EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
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B645GB285EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0448EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0487EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
10382902212611BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
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30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
18053326001021BHI BROTHCOPAN ITALIA SPAJSG2023-03-03
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