AccessGUDID - DEVICE: SPOTCHEM™ II Basic Panel 1 (00015482771263)

GUDID

Device Identifier (DI) Information

Brand Name: SPOTCHEM™ II Basic Panel 1
Version or Model: 77126
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ARKRAY USA, INC.

Primary DI Number: 00015482771263
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2024
Device Count: 25
Labeler D-U-N-S® Number*: 008171162 *Terms of Use

Device Description: Strip description for the invitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine concentration in human plasma from whole blood samples

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):	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?
46795	Magnesium (Mg2+) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE

FDA Premarket Submission

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

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: 4c5d2238-e620-4702-af73-32faa5e4fcc6
Public Version Date: May 31, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016