FDA.reportPublic FDA data

HardyDisk™

Primary DI
00816576029129
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z8411
Catalog number
Z841
Device description
Colistin, 10mcg, CT, for the differentiation of anaerobic bacteria based on susceptibility to Colistin, 1 x 50 disks, used as an aid in clarifying gram stain reaction of anaerobes, and in preliminary grouping of anaerobic gram-negative bacilli.
Published
2023-04-26
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
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
00816576029136PrimaryGS10
00816576029129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576029136008165760291368165760291360816576029136
00816576029129008165760291298165760291290816576029129

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anaerobic bacteria species culture isolate differentiation disc IVDOne or multiple diagnostic discs impregnated with a range of test reagents intended to be used in microbial testing for the presumptive identification of anaerobic bacteria isolated from a clinical specimen by culture.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
50
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
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
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
00848838022845REMELREMEL, INC.JTO2023-01-03