FDA.reportPublic FDA data

QuickScan (Windows 2000) Software, Version 2.02, and Key

Primary DI
M52516730010
Brand
QuickScan (Windows 2000) Software, Version 2.02, and Key
Company
HELENA LABORATORIES CORPORATION
Model
1673001
Published
2017-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQJDENSITOMETERIC, PROTEIN FRACTIONATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQJDensitometeric, Protein FractionationClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52516730010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Densitometry analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of the staining pattern intensity on film, acetate or other composite medium which has been created as the result of electrophoresis, thin-layer chromatography or immunoblot, to separate and/or visualize the individual components of a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)231-5663helena@helena.com

Regulatory Flags#

DUNS number
836287433
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M52551830AB-Trol 3 Coagulation Control51832016-08-18
M52551850Coagulation S.A.R.P (Specialty Assayed Reference Plasma)51852016-09-07
M52551860NORM-TROL 1 Coagulation Control51862016-09-07
M52551870AB-TROL 2 Coagulation Control51872016-09-07
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)53012016-09-07
M52553020Coagulation S.A.C.-2 (Specialty Assay Control)53022016-09-07
M52536110H-Pette without Blade (1000 pieces)36112017-05-26
M52536120H-Pette with Blade (1000 pieces)36122017-05-26
M52536130H-Pette Remover36132017-03-17
M52536150H-Pette II (No Blade, Metal Canula) (1000 pieces)36152017-05-26
M52594230IFE Free Lambda Light Chain Antiserum94232024-09-27
M5255527370SPIFE Nexus IFE-6 Antisera Kit5527372024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera Kit5527442024-09-27
M52594190IFE IgD Antiserum94192024-09-27
M52594200IFE IgE Antiserum94202024-09-27
M52594220IFE Free Kappa Light Chain Antiserum94222024-09-27
M52520050000ProtoFluor Z (110V)20050002017-03-17
M52520050020ProtoFluor Z (110V)20050022017-03-17
M52520060000ProtoFluor Z (220V)20060002017-03-17
M52518360V8 Urine Preparation Buffer18362023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M52510470000Optical Density Step Tablet (10-step)HELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52510310000Neutral Density Densitometer Control for QuickScanHELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516600020QuickScan 2000, (WINDOWS 2000)HELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516600030QuickScan 2000 (Windows 2000) Version 2.02 and small ScannerHELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516600040QuickScan 2000 (Windows 2000) Version 2.02 and V700 ScannerHELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516730000QuickScan 2000 Windows Software & KeyHELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516780000QuickScan 2000 Software, Version 2.02HELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516790000QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01HELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516900000QuickScan TouchHELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516900010QuickScan Touch, V800HELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516910000QuickScan Touch Software & KeyHELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516920000QuickScan Touch, Export Version 2HELENA LABORATORIES CORPORATIONJQJ2017-03-17
M52516920010QuickScan Touch, Export Version 2, V800HELENA LABORATORIES CORPORATIONJQJ2017-03-17