N/A

Primary DI
00819398022187
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
L28
Catalog number
L28
Device description
Loeffler's Slant, 5.5ml, 16x100mm tube, order by the package of 20 For the cultivation of Corynebacterium diphtheriae from clinical specimens.
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZICulture Media, Enriched

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398022194PrimaryGS10
00819398022187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022194008193980221948193980221940819398022194
00819398022187008193980221878193980221870819398022187

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
30382902218082BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00850056467063Schaedler Blood Agar OxyPlateOxyrase, Inc.KZI2023-11-30
00810144911120RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911144RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911151RediporAnalytiChem USA, Inc.KZI2023-09-21
05051716000155AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
05051716000162AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
00848838001505REMELREMEL, INC.KZI2023-01-04
00848838010965REMELREMEL, INC.KZI2023-01-04
00848838010972REMELREMEL, INC.KZI2023-01-04
00848838012136REMELREMEL, INC.KZI2023-01-04
00848838012174REMELREMEL, INC.KZI2023-01-04
00819398020565N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398020558N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398028431N/AHARDY DIAGNOSTICSKZI2020-09-02
00816576027576N/AHARDY DIAGNOSTICSKZI2020-06-08
00816576027613N/AHARDY DIAGNOSTICSKZI2020-06-08
00819398024228HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024242HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024266HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024235HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00816576027262N/AHARDY DIAGNOSTICSKZI2020-06-05
00816576027477N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023535N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023528N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398022194N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022293N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398028127N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022286N/AHARDY DIAGNOSTICSKZI2020-06-03