FDA.report

Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL

Primary DI
03661540304361
Brand
Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL
Company
ELITECHGROUP INC.
Model
SS-150
Device description
ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples.
Published
2020-10-16
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03661540304361PrimaryGS10

GMDN Terms

TermDefinition
Chloride (Cl-) IVD, controlA material which is used to verify the performance of 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 Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
052423787
Device count
1
DM exempt
false
Premarket exempt
true
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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