FDA.reportPublic FDA data

InTray® SAB+PVG

Primary DI
B088212730010
Brand
InTray® SAB+PVG
Company
BIO-MED DIAGNOSTICS, INC.
Model
2127
Device description
InTray SAB+PVG is for growth and observation of fungi, yeasts and dermatophytes. Inhibition is enhanced with the introduction of Polymyxin B, Vancomycin and Gentamicin.
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B088212730010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple dermatophyte species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of dermatophyte or other fungi isolated by culture from a clinical specimen.

Sterilization Methods#

Method table
Method

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
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
B08824830InTray® Mueller Hinton Chocolate Agar248322-483-0012019-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B6453P395EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
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B6453P275EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P390EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P256EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P330EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T0800EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0631EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
10382902978791BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
10382902981913BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
10382902216015BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
00848838001048REMELREMEL, INC.JSJ2023-01-03
00848838001055REMELREMEL, INC.JSJ2023-01-03
00848838001086REMELREMEL, INC.JSJ2023-01-03
00848838001093REMELREMEL, INC.JSJ2023-01-03
00848838001116REMELREMEL, INC.JSJ2023-01-03
00848838001437REMELREMEL, INC.JSJ2023-01-03
00848838001451REMELREMEL, INC.JSJ2023-01-03
00848838000119REMELREMEL, INC.JSJ2022-12-30
00848838000201REMELREMEL, INC.JSJ2022-12-30
00848838000348REMELREMEL, INC.JSJ2022-12-30
00848838000355REMELREMEL, INC.JSJ2022-12-30
00848838000423REMELREMEL, INC.JSJ2022-12-30
00848838000430REMELREMEL, INC.JSJ2022-12-30
00848838000447REMELREMEL, INC.JSJ2022-12-30
00848838000461REMELREMEL, INC.JSJ2022-12-30