Home GUDID 00657498001288 RaPET® s-LE
Primary DI 00657498001288
Brand RaPET® s-LE
Company STANBIO LABORATORY, L.P.
Model 1160-050
Catalog number 1160-050
Device description Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprotein factors associated with systemic Lupus Erythematosis in Human Serum.
Published 2016-09-24
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 LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00657498001288 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 00657498001288 00657498001288 657498001288 0657498001288
GMDN Terms# Term, Definition table Term Definition Multiple systemic lupus erythematosus (SLE)-associated antibody 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 qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) 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 00657498001950 Procalcitonin LiquiColor 2300-060 2300-060 2017-06-26 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
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