FDA.report

Sweat-Chek™ Calibrator, 90 mmol/L, 60 x 0.75mL

Primary DI
03661540302886
Brand
Sweat-Chek™ Calibrator, 90 mmol/L, 60 x 0.75mL
Company
ELITECHGROUP INC.
Model
SS-140
Device description
ELITechGroup's calibrator solution is for calibration of the Sweat-Chek™ Sweat Conductivity Analyzer.
Published
2020-10-14
Public version status
New
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

Product Codes

CodeName
JISCalibrator, Primary

Product Code Classifications

CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03661540302886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03661540302886036615403028863661540302886

GMDN Terms

TermDefinition
Chloride (Cl-) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of chloride (Cl-) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
052423787
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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