Home GUDID 00657498000854 Glycated Serum Protein Calibrator Set
Primary DI 00657498000854
Brand Glycated Serum Protein Calibrator Set
Company STANBIO LABORATORY, L.P.
Model 2360-401
Catalog number 2360-401
Device description Stanbio Glycated Serum Protein (GSP) Calibrator Kit is intended to be used for calibration of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062).
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name JIT Calibrator, Secondary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JIT Calibrator, Secondary Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00657498000854 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00657498000854 00657498000854 657498000854 0657498000854
GMDN Terms# Term, Definition table Term Definition Fructosamine IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00657498002094 Uri-Trak 120 M Urine Analyzer G1300-001 G1300-001 2023-06-08 00657498002322 HGB Controls - Low 3061-003 3061-003 2021-03-31 00657498002339 HGB Controls - Low 3061-006 3061-006 2021-03-31 00657498002346 HGB Controls - Normal 3062-003 3062-003 2021-03-31 00657498002353 HGB Controls - Normal 3062-006 3062-006 2021-03-31 00657498002360 HGB Controls - High 3063-003 3063-003 2021-03-31 00657498002377 HGB Controls - High 3063-006 3063-006 2021-03-31 00657498001806 Standard 1 A469-97 A469-97 2016-09-24 00657498000199 HemoPoint H2 DMS G3500-001 G3500-001 2016-09-24 00657498000380 Excel® Chemistry Analyzer G7700E-001 G7700E-001 2018-04-17 00657498000397 Excel® Chemistry Analyzer (Spanish) G7700S-001 G7700S-001 2018-04-17 00657498002179 STAT-Site WB Dual Analyte Measurement System 7000-001 7000-001 2019-11-18 00657498002193 STAT-Site WB Blood Glucose Test Strips 7010-025 7010-025 2019-11-18 00657498002209 STAT-Site WB Blood Glucose Test Strips 7010-050 7010-050 2019-11-18 00657498002216 STAT-Site WB Blood Glucose Test Strips 7010-100 7010-100 2019-11-18 00657498002230 STAT-Site WB B-Ketone Test Strips 7020-025 7020-025 2019-11-18 00657498002247 STAT-Site WB B-Ketone Test Strips 7020-050 7020-050 2019-11-18 00657498002254 STAT-Site WB B-Ketone Test Strips 7020-100 7020-100 2019-11-18 00657498002261 Blood Glucose Control Solution 7014-204 7014-204 2019-11-18 00657498002278 B-Ketone Control Solution 7024-204 7024-204 2019-11-18
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