S.G. Calibrator H

Basic Information

• Brand Name: S.G. Calibrator H
• Primary DI: 04987486053002
• Version / Model: 111581
• Catalog Number: N/A
• Company Name: ARKRAY USA, INC.
• Labeler DUNS: 008171162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 1
• Public Version Date: 2025-12-29
• Public Version Status: New
• Public Device Record Key: 01bf9878-2c4c-4973-b0d1-a06212ab1bfd

Device Description

The S.G. Calibrator H is used for calibration of the S.G. measurement system of the AUTION system. The S.G. Calibrator establishes reference points based on the physical principles of AUTION analyzers.

Device Characteristics

• Single Use: Yes
• 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
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35918	Urine analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987486053002	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a refrigerator, avoiding exposure to light.
• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit