FDA.reportPublic FDA data

N/A

Primary DI
00819398022903
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Q34
Catalog number
Q34
Device description
Sabouraud Dextrose (SabDex) Agar with Chloramphenicol, 20x125mm glass tube, 18ml fill, order by the package of 20 Sabourauds Dextrose Agar with Chloramphenicol for the selective isolation of fungi.
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
00819398022910PrimaryGS10
00819398022903Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022910008193980229108193980229100819398022910
00819398022903008193980229038193980229030819398022903

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@hardydiagnosticcs.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

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Primary DI, Brand, Model table
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00819398024594N/AY100Y1002020-06-08
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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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