FDA.reportPublic FDA data

Q-Slide™

Primary DI
00816576028931
Brand
Q-Slide™
Company
HARDY DIAGNOSTICS
Model
Z301
Catalog number
Z301
Device description
Q-Slide™ AFB, a prepared control slide for QC of the AFB (acid fast) stain, contains a mycobacterium and corynebacteruim sp., 5 slides per boxA convenient ready-to-stain control slide that will test both your stain solutions and your staining techniques. Positive and negative stain control organisms are affixed to the circles in each Q-Slide™. Up to four patient specimens (in the squares) may be processed at the same time as the QC organisms.
Published
2020-08-07
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
LJGQuality Control Slides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028931PrimaryGS10
00816576028924Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028931008165760289318165760289310816576028931
00816576028924008165760289248165760289240816576028924

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain control IVDA prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819398026086N/AY62Y622020-06-09
00816576027194HardyDisk™Z9495Z94952025-08-08
00816576027200HardyDisk™Z9491Z94912025-08-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B502BSB9420CS0Tryptase Control SlidesBIO SB, INC.LJG2025-03-28
B502BSB0307CS05-Core Multi-Infectious Disease Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0308CS02-Core SV-40 Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0310CS02-Core Adenovirus Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9000CS0A-1-Antichymotrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9001CS0A-1-Antitrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9002CS0ACE2 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9003CS0ACTH Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9004CS0Actin Muscle Specific Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9005CS0Actin Smooth Muscle Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9006CS0Adenovirus Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9007CS0Adipophilin/ADRP Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9008CS0Albumin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9010CS0ALK-1/CD246 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9011CS0Alpha Synuclein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9012CS0Alpha-Fetoprotein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9013CS0AMACRacemase/P504S Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9014CS0Amyloid A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9015CS0Amyloid Beta Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9016CS0Androgen Receptor Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9017CS0Annexin A1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9018CS0Annexin VII Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9019CS0Arginase-1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9020CS0ARID1A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9021CS0ATM Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9022CS0ATRX Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9023CS0Aurora B Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9024CS0B7H3/CD276 Control SlidesBIO SB, INC.LJG2025-03-18