FDA.reportPublic FDA data

N/A

Primary DI
00819398027175
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
ML1
Catalog number
ML1
Device description
McFarland Standard, Latex Equivalent # 1, 8ml fill, 16x100mm tubeThe McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTAMonitor, Microbial Growth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTAMonitor, Microbial GrowthMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398027175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398027175008193980271758193980271750819398027175

GMDN Terms#

Term, Definition table
TermDefinition
McFarland standard IVDA standard solution intended to be used as a reference in the estimation of the number of bacteria in a suspension based on the turbidity, compared to that of the McFarland standard. It consists of specified volumes of barium chloride and sulphuric acid. The standard is typically used to adjust the inoculum in microbial assays (e.g., microbial susceptibility and microbial identification) where a standardized inoculum is required.

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@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
07613336146996cobas® Microbial Inactivation SolutionRoche Diagnostics GmbHJTA2026-03-26
30382902495605BD BACTEC™ Subculturing/Aerobic Venting UnitBECTON, DICKINSON AND COMPANYJTA2024-09-17
60382902495606BD BACTEC™ Subculturing/Aerobic Venting UnitBECTON, DICKINSON AND COMPANYJTA2024-09-17
08056040148778LIGHT SCATTERING TEST KITALIFAX SRLJTA2022-10-20
08056040140086URO-QUICK SCREENING KITALIFAX SRLJTA2022-10-06
08056040140291ALFRED 60ALIFAX SRLJTA2022-10-06
08056040140307HB&L UROQUATTROALIFAX SRLJTA2022-10-06
08056040140352ALFRED 60/ASTALIFAX SRLJTA2022-10-06
08056040141168POSITIVE CONTROL KITALIFAX SRLJTA2022-10-06
08056040141182AUTOMATION KITALIFAX SRLJTA2022-10-06
08056040141281URO-QUICK RAA KITALIFAX SRLJTA2022-10-06
08056040141502HB&L UROQUATTRO LIGHTALIFAX SRLJTA2022-10-06
08056040142615RAA BACTERIAL REAGENT PACKALIFAX SRLJTA2022-10-06
00819398026901N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026918N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026925N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026932N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026949N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026956N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026963N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398027168N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398021678N/AHARDY DIAGNOSTICSJTA2020-06-02
30382902710562BD BBL™ Venting UnitBECTON, DICKINSON AND COMPANYJTA2018-05-25