AccessGUDID - DEVICE: AutoDELFIA hAFP Kit (06438147321315)

GUDID

Device Identifier (DI) Information

Brand Name: AutoDELFIA hAFP Kit
Version or Model: B079-201
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B079-201
Company Name: Wallac Oy

Primary DI Number: 06438147321315
Issuing Agency: GS1
Commercial Distribution End Date: October 04, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)

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):	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?
54060	Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970037	000
P970037	009
P970037	010
P970037	011

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: 274039f8-e811-4900-85c7-1fb653256ce3
Public Version Date: November 25, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2014