AccessGUDID - DEVICE: Negative Control Serum (10888234400592)

GUDID

Device Identifier (DI) Information

Brand Name: Negative Control Serum
Version or Model: 628209
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 628209
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234400592
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: For Use with LIFECODES Class I ID

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:	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?
56324	HLA class I antigen tissue typing IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I antigens in a clinical specimen, using a multiplex method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZI	Test,Qualitative,For Hla,Non-Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK040035	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: 58b5c2bc-865b-49fd-954e-baf01e2530f0
Public Version Date: January 10, 2019
Public Version Number: 4
DI Record Publish Date: September 15, 2016