FDA.report

Sirrus® ISE Calibrator 2

Primary DI
00657498001769
Brand
Sirrus® ISE Calibrator 2
Company
STANBIO LABORATORY, L.P.
Model
20270478
Catalog number
20270478
Device description
The ISE Calibrator 2 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications

CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498001769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001769006574980017696574980017690657498001769

GMDN Terms

TermDefinition
Multiple clinical chemistry analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
1
DM exempt
false
Premarket exempt
false
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

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