AccessGUDID - DEVICE: ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) (05055273216486)

GUDID

Device Identifier (DI) Information

Brand Name: ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)
Version or Model: LV10366
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LV10366
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273216486
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays.

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?
30213	Multiple clinical chemistry enzyme IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

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 -24 and -18 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 513e3c0b-fd66-43e6-b785-42f068cd4919
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: July 15, 2020