AccessGUDID - DEVICE: Pointe Scientfic, Inc. (00811727012562)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientfic, Inc.
Version or Model: HA965-324
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HA965-324
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727012562
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Amylase EPS Reagent Set for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Packaged at 12 x 22ml, 6 x 10ml

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?
52940	Total amylase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total amylase in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIJ	Saccharogenic, Amylase

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: 80bc243b-52f9-4230-8a9d-82b9e72cd506
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: August 31, 2016