FDA.report

N/A

Primary DI
00819398023344
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R30
Catalog number
R30
Device description
Tryptic Soy Broth (TSB), 5ml fill, 13x100mm tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms.
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

Related Records

Contact Domains

Product Codes

CodeName
JSCCulture Media, General Nutrient Broth

Product Code Classifications

CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819398023351PrimaryGS10
00819398023344Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398023351008193980233518193980233510819398023351
00819398023344008193980233448193980233440819398023344

GMDN Terms

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

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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