FDA.reportPublic FDA data

Optical Density Step Tablet (10-step)

Primary DI
M52510470000
Brand
Optical Density Step Tablet (10-step)
Company
HELENA LABORATORIES CORPORATION
Model
1047000
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
M52510470000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Optical laboratory instrument performance standard calibrator/control IVD, reusableA solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.

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

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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
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
M52516730010QuickScan (Windows 2000) Software, Version 2.02, and 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