N Latex ADNase B (USA)

Basic Information

• Brand Name: N Latex ADNase B (USA)
• Primary DI: 00630414285054
• Version / Model: 10873691
• Catalog Number: OWTI15
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-07
• Public Version: 3
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: a5e4af88-e15e-45b1-989e-28deff9f27b4

Device Description

Quantitative determination of ADNase B in human serum on BN Systems

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
GTR	ANTIDEOXYRIBONUCLEASE, STREPTOCOCCUS SPP.	Microbiology	866.3720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51732	Beta-haemolytic Group A Streptococcus DNAse B antibody 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 antibodies to DNAse B enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414285054	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius