AccessGUDID - DEVICE: Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) (05051700006170)

GUDID

Device Identifier (DI) Information

Brand Name: Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II)
Version or Model: LK009.2TB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE BINDING SITE GROUP LIMITED

Primary DI Number: 05051700006170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 347045614 *Terms of Use

Device Description: Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) - Bulk Kit

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
53787	Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012292	000

Device Exempt from Premarket Submission: No 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: 4e10b2cc-253d-43ed-8b71-1cb6f657dfee
Public Version Date: September 14, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016