FDA.reportPublic FDA data

N/A

Primary DI
00819398022309
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
L40
Catalog number
L40
Device description
Sabdex (Sabouraud Dextrose) Agar Slant, 10ml, 20x125mm tube, order by the package of 20 (Sabourauds Dextrose Agar) For the cultivation of fungi.
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00819398022316PrimaryGS10
00819398022309Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022316008193980223168193980223160819398022316
00819398022309008193980223098193980223090819398022309

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 Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576027958N/AW95W952020-06-08
00819398024594N/AY100Y1002020-06-08
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00816576027088HardyDisk™Z9491Z94912025-08-08
00816576026975HardyDisk™Z9485Z94852025-07-14
00816576027439 QwikIDIG06020C03IG06020C032025-06-23
00819398027199N/AZ134Z1342020-06-10
00819398027779N/AZ135Z1352020-06-10
00816576023516N/A102010202020-05-26
00816576025800TransPROTPV50TPV502024-10-08
00816576026951N/AG367G3672024-07-08
00816576026586N/AJ139J1392020-05-20
00816576026876N/AR12R122024-03-08
00819398021593N/AR63BXR63BX2024-01-15
00819398020602N/AK02K022020-05-24
00816576026838HardyCHROM™J28J282023-12-08
00816576024391AnaeroGROAG051AG0512020-05-12
00819398020725HardyDisk™Z9465Z94652023-11-21
00819398023627N/AR80R802020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06955792701557Sample Storage ReagentSansure Biotech Inc.JSG2025-09-18
06955792701564Sample Storage ReagentSansure Biotech Inc.JSG2025-09-18
06955792701571Sample Storage ReagentSansure Biotech Inc.JSG2025-09-18
06955792701649Sample Storage ReagentSansure Biotech Inc.JSG2025-09-18
06955792701656Sample Storage ReagentSansure Biotech Inc.JSG2025-09-18
05032384126453PEPTONE WATER (ANDRADE)OXOID LIMITEDJSG2025-06-27
B645T04661EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T04861EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T07491EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T07591EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B6451B2651EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6451R0071EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645GB4771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T00061EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T02461EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6452P1951EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P1451EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P4591EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645EB285EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645GB225EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645GB2851EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645PB50EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645TT04481EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T04871EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
30382902212615BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
05032384000975NUTRIENT BROTHOXOID LIMITEDJSG2024-06-03
05032384001002NUTRIENT AGAROXOID LIMITEDJSG2024-06-03
05032384282623NUTRIENT BROTHOXOID LIMITEDJSG2024-06-03
26972698600405KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
26972698600412KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05