AccessGUDID - DEVICE: Albumin BCP (6x20 mL) (08058056681973)

GUDID

Device Identifier (DI) Information

Brand Name: Albumin BCP (6x20 mL)
Version or Model: C22855
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C22855
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056681973
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The Albumin BCP (6x20 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only.

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?
53599	Albumin 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 quantitative measurement of albumin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CJW	Bromcresol Purple Dye-Binding, Albumin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Store between 15 and 30 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 120 Milliliter

Device Record Status

Public Device Record Key: 036eb04a-48c7-4080-be21-297e5e30a10f
Public Version Date: March 03, 2020
Public Version Number: 1
DI Record Publish Date: February 24, 2020