AccessGUDID - DEVICE: ALDOLASE LEVEL 3 CONTROL (ALS CONTROL 3) (05055273200102)

GUDID

Device Identifier (DI) Information

Brand Name: ALDOLASE LEVEL 3 CONTROL (ALS CONTROL 3)
Version or Model: AD5002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AD5002
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273200102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *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:	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?
45826	Aldolase IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of aldolase in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131776	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41bee628-89a9-45a7-bb03-f9d12ce8879e
Public Version Date: June 11, 2019
Public Version Number: 1
DI Record Publish Date: June 03, 2019