FDA.reportPublic FDA data

N/A

Primary DI
00816576026425
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
J108
Catalog number
J108
Device description
TSA / TSA, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Tryptic Soy Agar is recommended for use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance and transportation of pure cultures of microorganisms.
Published
2020-05-20
Public version status
Update
Distribution status
Not 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
00816576026425PrimaryGS10
00816576026418Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576026425008165760264258165760264250816576026425
00816576026418008165760264188165760264180816576026418

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 Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
10
Premarket exempt
true
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