AccessGUDID - DEVICE: UniQ® PINP RIA (06438115000082)

GUDID

Device Identifier (DI) Information

Brand Name: UniQ® PINP RIA
Version or Model: 67034
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 67034
Company Name: Aidian Oy

Primary DI Number: 06438115000082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401656868 *Terms of Use

Device Description: UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentration of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum.

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?
61762	Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of procollagen type I N-terminal propeptide (PINP) in a clinical specimen, using a radioimmunoassay method. PINP is an indicator of osteoblastic activity and used in the management of postmenopausal osteoporosis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043125	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: 518894c3-2a06-4e78-8ab9-2a18cb6ede20
Public Version Date: March 02, 2020
Public Version Number: 5
DI Record Publish Date: April 13, 2016