AccessGUDID - DEVICE: Angiotensin II RIA (EBUHRKA221)

GUDID

Device Identifier (DI) Information

Brand Name: Angiotensin II RIA
Version or Model: RK-A22
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RK-A22
Company Name: Bühlmann Laboratories AG

Primary DI Number: EBUHRKA221
Issuing Agency: HIBCC
Commercial Distribution End Date: November 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 481261006 *Terms of Use

Device Description: The BÜHLMANN Angiotensin II is a double antibody radioimmunoassay designed for the quantitative in vitro diagnostic determination of immunoreactive Angiotensin II in extracted EDTA plasma.

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):	No
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?
52945	Angiotensin converting enzyme (ACE) 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 qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIB	Radioimmunoassay, Angiotensin I And Renin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954299	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: 46385785-b5b3-4175-a282-e7c9e5f16624
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016