FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380158948
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CHB-GS-QC
Catalog number
CHB-GS-QC
Device description
Control Slides for use with Single Slide Automate Gram Stainer
Published
2018-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
50885380158948PrimaryGS10
10885380158940Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538015894850885380158948
1088538015894010885380158940

GMDN Terms#

Term, Definition table
TermDefinition
Gram stain IVD, controlA prepared slide and/or other associated material used to verify the performance of a Gram stain/staining kit (also referred to as Brown and Benn or Brown-Hopps stain) which is intended to be used for the demonstration and differentiation of bacteria in biological/clinical specimens.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

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