FDA.reportPublic FDA data

N/A

Primary DI
00816576027798
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
W70
Catalog number
W70
Device description
SabDex (Sabouraud Dextrose) Agar, USP, for cultivation of yeast and fungi, 15x100mm plate, order by the package of 10Sabouraud Dextrose Agar is recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts, and meet the harmonized USP/EP/JP standards for the microbial examination of non sterile products.
Published
2020-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00816576027798PrimaryGS10
00816576027781Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576027798008165760277988165760277980816576027798
00816576027781008165760277818165760277810816576027781

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient agar culture medium IVDA non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B645T0466EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0486EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0749EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0759EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B6451B265EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6451R007EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645GB477EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0006EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0246EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6452P195EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P145EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P459EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
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
16972698600408KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
18053326001021BHI BROTHCOPAN ITALIA SPAJSG2023-03-03
00848838002878REMELREMEL, INC.JSG2022-12-23
00848838002946REMELREMEL, INC.JSG2022-12-23
00848838002960REMELREMEL, INC.JSG2022-12-23
00848838003363REMELREMEL, INC.JSG2022-12-23
00848838003394REMELREMEL, INC.JSG2022-12-23
00848838003721REMELREMEL, INC.JSG2022-12-23
00848838003912REMELREMEL, INC.JSG2022-12-23
00848838004537REMELREMEL, INC.JSG2022-12-23
00848838004575REMELREMEL, INC.JSG2022-12-23
00848838004612REMELREMEL, INC.JSG2022-12-23