STEROID-SKREEN

Basic Information

• Brand Name: STEROID-SKREEN
• Primary DI: 00810042681897
• Version / Model: 35061703
• Catalog Number: 35061703
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• Labeler DUNS: 028007698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-08
• Public Version: 2
• Public Version Date: 2022-01-11
• Public Version Status: Update
• Public Device Record Key: 612f9c57-5c22-4782-a56d-c4706993656b
• Distribution End Date: 2022-01-10

Device Description

SODIUM HYDROXIDE, 3N, 2.65L

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCY	Zimmerman (Spectrophotometric), 17-Ketosteroids	Clinical Chemistry	862.1430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54050	17-Ketosteroid (17KS) 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 17-ketosteroids (17KS) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042681897	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius