Home GUDID 00817302020281 CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227
Primary DI 00817302020281
Brand CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227
Company CAROLINA LIQUID CHEMISTRIES CORPORATION
Model BL227
Catalog number BL227
Device description AMY (Amylase) 3 x 170 tests
Published 2016-09-01
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 false Product Codes# Code, Name table Code Name JFJ CATALYTIC METHODS, AMYLASE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JFJ Catalytic Methods, Amylase Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817302020281 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 00817302020281 00817302020281 817302020281 0817302020281
GMDN Terms# Term, Definition table Term Definition Alpha-amylase isoenzyme IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an alpha-amylase isoenzyme (e.g., salivary or pancreatic) and/or to determine its enzymatic activity in a clinical specimen, using a spectrophotometry method. This test is typically used to aid the diagnosis and monitoring of various conditions including pancreatic disease, salivary disease, and conditions associated with the overproduction of alpha-amylase (e.g., mental and physical stress, stress-related psychosomatic disorders, fibromyalgia).
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Total Volume 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Reagent is stable when stored at 2-8° C until expiration date Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 962385787 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 00817302020274 CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227 ST227 ST227 2016-09-01 00817302020298 CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227 AU-227 AU-227 2016-09-01 00817302020304 CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227 CC227 CC227 2016-09-01 00817302022964 CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227 DT227 DT227 2016-10-17 00817302020182 CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224 BL-224. BL-224. 2016-09-01 00817302020199 CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224 ST224 ST224 2016-09-01 00817302020205 CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224 AU-224 AU-224 2016-09-01 00817302020212 CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224 CC224 CC224 2016-09-01 00817302020229 CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214 CC214 CC214 2016-09-01 00817302020946 CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 AU-214 AU-214 2016-09-01 00817302022957 CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224 DT224 DT224 2016-10-17 00817302021912 CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT BL-419B BL419B BL419B 2016-09-01 00817302020786 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425 BL425 BL425 2016-09-01 00817302020809 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425 AU-425 AU-425 2016-09-01 00817302020816 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 DT425 DT425 2016-09-01 00817302020847 CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424 AU-424 AU-424 2016-09-01 00817302021066 CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412 AU-412 AU-412 2016-09-01 00817302021127 CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT AU-417 AU-417 AU-417 2016-09-01 00817302021189 CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418 AU-418 AU-418 2016-09-01 00817302021257 CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT AU-413 AU-413 AU-413 2016-09-01
Other Devices Sharing Product Codes# 
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