FDA.report

CARDINAL HEALTH

Primary DI
10885380158889
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CHB-AGS
Catalog number
CHB-AGS
Device description
Single Slide Automated Gram Stainer
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KPASlide stainer, automated

Product Code Classifications

CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380158889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538015888910885380158889

GMDN Terms

TermDefinition
Microscope slide stainer IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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