AccessGUDID - DEVICE: Cytomegalovirus 10wl/10 pk (00813545025502)

GUDID

Device Identifier (DI) Information

Brand Name: Cytomegalovirus 10wl/10 pk
Version or Model: I-CMV01X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I-CMV01X
Company Name: SCIMEDX CORPORATION

Primary DI Number: 00813545025502
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 155424708 *Terms of Use

Device Description: No description.

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:	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?
49707	Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K882835	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e77626f-ddeb-4b25-a05a-346b32c23309
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016