AccessGUDID - DEVICE: MedTest DX Lipoprotein (a) Calibrator (00817439021076)

GUDID

Device Identifier (DI) Information

Brand Name: MedTest DX Lipoprotein (a) Calibrator
Version or Model: LPAC400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LPAC400
Company Name: Medtest Dx, Inc.

Primary DI Number: 00817439021076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070371210 *Terms of Use

Device Description: Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 ml.

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?
41417	Lipoprotein A IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	Calibrator, Primary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011568	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
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: cd52b6c8-d14b-434c-ad65-6503bf2e289b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2016