Optical Density Step Tablet (10-step)

Basic Information

• Brand Name: Optical Density Step Tablet (10-step)
• Primary DI: M52510470000
• Version / Model: 1047000
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 836287433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-17
• Public Version: 5
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: ea2ca569-417c-4f60-aa60-fd74d1322e6b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQJ	DENSITOMETERIC, PROTEIN FRACTIONATION	Clinical Chemistry	862.1630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58049	Optical laboratory instrument performance standard calibrator/control IVD, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52510470000	HIBCC

Customer Contacts

• Phone: [phone] ext. 1600
• Email: [email protected]