Home GUDID 00896863002028 Sweat Control Level 1, 2, & 3 Set 9x3mL
Primary DI 00896863002028
Brand Sweat Control Level 1, 2, & 3 Set 9x3mL
Company QUANTIMETRIX CORPORATION
Model 1190-01
Catalog number 1190-01
Device description The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures and to validate the analysis of Chloride, Potassium, and Sodium by confirmatory methods used to quantitate patient samples. They are liquid, ready-to-use, requiring no reconstitution or dilution. They are supplied in three levels, nine vials per box, 3x3mL each level. They are prepared in an aqueous simulated human sweat matrix to which preservatives have been added.
Published 2018-09-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name JJR Electrolyte Controls (Assayed And Unassayed)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JJR Electrolyte Controls (Assayed And Unassayed) Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00896863002028 Primary GS1 0 M0511190011 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00896863002028 00896863002028 896863002028 0896863002028
GMDN Terms# Term, Definition table Term Definition Multiple electrolyte IVD, control A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 18 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 010717890 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00896863002424 Chromascopics Control Level 1&2 Set 2x25mL (International) 1540-03 1540-03 2023-05-04 00896863002356 QuanTtest Human Protein Standards Set 3410-02 3410-02 2021-09-10 00896863002004 Dropper Spinal Fluid Control Level 1 Set 3x3mL 1451-31 1451-31 2018-09-26 00896863002011 Dropper Spinal Fluid Control Level 2 Set 3x3mL 1452-31 1452-31 2018-09-26 00896863002073 Dropper Spinal Fluid Control Level 1&2 Set 2x3mL 1450-01 1450-01 2018-09-26 00896863002042 Chromascopics Control Level 1&2 Set 4x120mL (Domestic) 1540-02 1540-02 2018-09-26 00896863002066 Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL 1510-02 1510-02 2018-09-26 00896863002349 QuanTtest Red Pyrogallol Red Reagent 5210-12 5210-12 2019-09-27 00896863002394 Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL 1470-02 1470-02 2019-03-13 00896863002035 Chromascopics Control Level 1&2 Set 4x120mL (International) 1540-01 1540-01 2018-09-26 00896863002059 Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL 1290-01 1290-01 2018-09-26 00896863002080 Spinalscopics Control Level 1 Set 3x3mL 1461-31 1461-31 2018-09-26 00896863002097 Spinalscopics Control Level 2 Set 3x3mL 1462-31 1462-31 2018-09-26 00896863002103 Microbumin Microalbumin Control Level 1&2 Set 10x7mL 1250-01 1250-01 2018-09-26 00896863002110 Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL 1440-02 1440-02 2018-09-26 00896863002127 Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL 1440-03 1440-03 2018-09-26 00896863002134 Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL 1440-01 1440-01 2018-09-26 00896863002141 Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL 1442-61 1442-61 2018-09-26 00896863002158 Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL 1440-04 1440-04 2018-09-26 00896863002165 Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL 1440-06 1440-06 2018-09-26
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00304040002575 Henry Schein HENRY SCHEIN, INC. JJR 2016-09-24
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