FDA.reportPublic FDA data

N/A

Primary DI
00819398022606
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Q01
Catalog number
Q01
Device description
Agar Deep, 1.5%, (Water Agar), 16x125mm pour tube, 9ml Deep, order by the package of 20 Hardy Diagnostics Agar, 1.5% (Water Agar) is used in the Kirby-Bauer alternative agar-overlay method of inoculation for antimicrobial disk diffusion susceptibility testing and for microbiological procedures that require an additive-free solid medium, such as in performing colony counts, testing antimicrobial disk potency, or in performing the modified fungal slide culture method.
Published
2020-06-04
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
00819398022613PrimaryGS10
00819398022606Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022613008193980226138193980226130819398022613
00819398022606008193980226068193980226060819398022606

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
true
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

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Primary DI, Brand, Company table
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06955792701656Sample Storage ReagentSansure Biotech Inc.JSG2025-09-18
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B645T00061EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
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B6452P1951EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P1451EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P4591EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
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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
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