FDA.report

N/A

Primary DI
00819398022262
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
L36
Catalog number
L36
Device description
BHI (Brain Heart Infusion) Agar Slant, 5.5ml fill, 16x100mm tube, order by the package of 20 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
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

Related Records

Contact Domains

Product Codes

CodeName
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819398022279PrimaryGS10
00819398022262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022279008193980222798193980222790819398022279
00819398022262008193980222628193980222620819398022262

GMDN Terms

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

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
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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