DRG:HYBRiD.XL®

Basic Information

• Brand Name: DRG:HYBRiD.XL®
• Primary DI: 00404847452525
• Version / Model: HYB-5252
• Catalog Number: HYB-5252
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 08e9313b-1d8b-4960-97fd-d73226226bbd

Device Description

The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
JJQ	COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE	Clinical Chemistry	862.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62413	Nephelometry/turbidimetry analyser IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of light absorption and/or light scatter caused by particles (e.g., bacteria) and/or other biological components suspended in a clinical specimen using a photometric detection system. It is generally used to measure the concentration of a target analyte in solution.	No	Active
56718	Enzyme immunoassay (EIA) analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00404847452525	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius