AccessGUDID - DEVICE: N Latex ADNase B (USA) (00630414285054)

GUDID

Device Identifier (DI) Information

Brand Name: N Latex ADNase B (USA)
Version or Model: 10873691
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OWTI15
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414285054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Quantitative determination of ADNase B in human serum on BN Systems

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTR	ANTIDEOXYRIBONUCLEASE, STREPTOCOCCUS SPP.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5e4af88-e15e-45b1-989e-28deff9f27b4
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: July 07, 2020