FDA.reportPublic FDA data

HardyDisk™

Primary DI
00816576028399
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z7081
Catalog number
Z7081
Device description
ALA Disks™, delta-aminolevulinic acid, for the differentiation and speciation of Haemophilus spp, a porphyrin test, 1 x 50 disksA useful aid for differentiating species of Haemophilus
Published
2020-08-07
Public version status
Update
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
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028399PrimaryGS10
00816576028382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028399008165760283998165760283990816576028399
00816576028382008165760283828165760283820816576028382

GMDN Terms#

Term, Definition table
TermDefinition
Porphyrin precursor IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple porphyrin precursors (e.g., porphobilinogen [PBG], delta-aminolaevulinic acid [delta-ALA]) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
50
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
00848838059865^BM^ PK/50 OXIDASE TESTREMEL, INC.JTO2026-01-16
05032384007080BLANK DISCSOXOID LIMITEDJTO2024-07-11
05032384188796Oxoid™ Bacitracin Diagnostic DiscsOXOID LIMITEDJTO2024-07-08
00816576025121N/AHARDY DIAGNOSTICSJTO2024-01-08
00819398021586N/AHARDY DIAGNOSTICSJTO2024-01-08
00810144911229RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911236RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911243RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911250RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911267RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911274RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911281RediporAnalytiChem USA, Inc.JTO2023-09-21
00816576029136HardyDisk™HARDY DIAGNOSTICSJTO2023-04-26
00816576029129HardyDisk™HARDY DIAGNOSTICSJTO2023-04-26
00848838002106REMELREMEL, INC.JTO2023-01-03
00848838004131REMELREMEL, INC.JTO2023-01-03
00848838008672REMELREMEL, INC.JTO2023-01-03
00848838022357REMELREMEL, INC.JTO2023-01-03
00848838022395REMELREMEL, INC.JTO2023-01-03
00848838022517REMELREMEL, INC.JTO2023-01-03
00848838022531REMELREMEL, INC.JTO2023-01-03
00848838022579REMELREMEL, INC.JTO2023-01-03
00848838022593REMELREMEL, INC.JTO2023-01-03
00848838022616REMELREMEL, INC.JTO2023-01-03
00848838022630REMELREMEL, INC.JTO2023-01-03
00848838022678REMELREMEL, INC.JTO2023-01-03
00848838022715REMELREMEL, INC.JTO2023-01-03
00848838022746REMELREMEL, INC.JTO2023-01-03
00848838022784REMELREMEL, INC.JTO2023-01-03
00848838022821REMELREMEL, INC.JTO2023-01-03