FDA.report

CARDINAL HEALTH

Primary DI
10885380175596
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
UAREADER2
Catalog number
UAREADER2
Device description
Semi-Auto Urine Analyzer For Urine Light Weight Compact Design Full Duplex Communication Interface Internal/external Printer Interface Easy Cleaning Display in 8 Languages UAREADER2
Published
2020-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KQOAUTOMATED URINALYSIS SYSTEM

Product Code Classifications

CodeDeviceSpecialtyClass
KQOAutomated Urinalysis SystemClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380175596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538017559610885380175596

GMDN Terms

TermDefinition
Urine analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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