AccessGUDID - DEVICE: G7 Variant Elution Buffer HSi No.3 (S) (04560189283473)

GUDID

Device Identifier (DI) Information

Brand Name: G7 Variant Elution Buffer HSi No.3 (S)
Version or Model: N/A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TOSOH CORPORATION

Primary DI Number: 04560189283473
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 690571724 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
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?
53313	Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a liquid chromatography method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	Assay, Glycosylated Hemoglobin

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 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2885af40-839b-4a8b-9abb-5fe9e94bdd55
Public Version Date: April 01, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016