AccessGUDID - DEVICE: Negative Serum Control (10888234500537)

GUDID

Device Identifier (DI) Information

Brand Name: Negative Serum Control
Version or Model: 404576
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 404576
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234500537
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: For Use with PakAuto

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:	No
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?
56579	Human platelet antigen (HPA) multiple antibody screening/identification 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 in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYP	Test,Platelet Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK960059	0

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: 441b0033-57da-4f2c-868d-7ae63fda3ae0
Public Version Date: August 01, 2018
Public Version Number: 4
DI Record Publish Date: July 07, 2016