AccessGUDID - DEVICE: Sirrus® ALT/SGPT Liqui-UV® (00657498001677)

GUDID

Device Identifier (DI) Information

Brand Name: Sirrus® ALT/SGPT Liqui-UV®
Version or Model: S2930-600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S2930-600
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498001677
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: For the Kinetic Quantitative Determination of ALT/GPT in Serum and Plasma.

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?
52923	Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt

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: fb54a48c-b081-4591-a811-295088744415
Public Version Date: April 16, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016