Home GUDID 00657498001950 Procalcitonin LiquiColor
Primary DI 00657498001950
Brand Procalcitonin LiquiColor
Company STANBIO LABORATORY, L.P.
Model 2300-060
Catalog number 2300-060
Device description Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determination of PCT in human serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. This test is used in conjunction with other laboratory tests and clinical examinations to aid in the risk assessment of ill patients on their initial hospital admission for the potential development of sepsis and/ or septic shock.
Published 2017-06-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00657498001950 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 00657498001950 00657498001950 657498001950 0657498001950
GMDN Terms# Term, Definition table Term Definition Procalcitonin (PCT) IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of procalcitonin (PCT) 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 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 00657498000434 Albumin LiquiColor® 0285-500 0285-500 2016-09-23 00657498001516 Sirrus® Albumin LiquiColor® S0285-750 S0285-750 2016-09-23 00657498000847 Glycated Serum Protein (GSP) LiquiColor® 2350-062 2350-062 2016-09-23 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 00657498000427 Acetaminophen Liquicolor® 2400-060 2400-060 2016-09-23 00657498000441 Alkaline Phosphatase LiquiColor® 2900-430 2900-430 2016-09-23 00657498000458 Alkaline Phosphatase LiquiColor® 2900-500 2900-500 2016-09-23 00657498000489 a-Amylase LiquiColor® 2970-430 2970-430 2016-09-23 00657498000496 AST/SGOT Liqui-UV® 2920-430 2920-430 2016-09-23 00657498000502 AST/SGOT Liqui-UV® 2920-500 2920-500 2016-09-23 00657498000519 B-Hydroxybutyrate LiquiColor® 2440-058 2440-058 2016-09-23 00657498000526 Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® B2440-180 B2440-180 2016-09-23
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