FDA.report

N/A

Primary DI
00819398022286
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
L37
Catalog number
L37
Device description
Chocolate Agar Slant, 5.5ml, 16x100mm tube, order by the package of 20 (GC Agar Base with 1% hemoglobin and enrichments) For the cultivation of fastidious bacteria.
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
KZICulture Media, Enriched

Product Code Classifications

CodeDeviceSpecialtyClass
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819398022293PrimaryGS10
00819398022286Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022293008193980222938193980222930819398022293
00819398022286008193980222868193980222860819398022286

GMDN Terms

TermDefinition
Enriched agar culture medium IVDAn agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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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