AccessGUDID - DEVICE: Capture-CMV Indicator Red Cells (10888234001232)

GUDID

Device Identifier (DI) Information

Brand Name: Capture-CMV Indicator Red Cells
Version or Model: 0066238
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0066238
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Capture-CMV Indicator Red Cells are part of the Capture-CMV test, and they are used to visualize the final reaction.

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):	Yes
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?
49710	Cytomegalovirus (CMV) antigen 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 antigens from cytomegalovirus (CMV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJO	Antigen, Iha, Cytomegalovirus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K910003	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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1a9d07a-917b-4c10-9590-a213ac1ff4cb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2016