AccessGUDID - DEVICE: AMY (05055273200560)

GUDID

Device Identifier (DI) Information

Brand Name: AMY
Version or Model: AY1580
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AY1580
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273200560
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.

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:	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?
52943	Amylase isoenzyme IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple amylase isoenzymes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIJ	Saccharogenic, Amylase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953211	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
Special Storage Condition, Specify: Stable for 21 days at +2 to + 8°C once reconstituted.
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: a0a88505-e43f-4ad5-98df-034c830a942a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016