AccessGUDID - DEVICE: Ehrlichia chaffeensis 12wl; 10 pk (00813545025649)

GUDID

Device Identifier (DI) Information

Brand Name: Ehrlichia chaffeensis 12wl; 10 pk
Version or Model: I-ECH01X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I-ECH01X
Company Name: SCIMEDX CORPORATION

Primary DI Number: 00813545025649
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?
51397	Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Ehrlichia chaffeensis in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Ehrlichia chaffeensis, the rickettsial bacteria associated with human monocytic ehrlichiosis (HME).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSQ	Reagent, Rickettsia Serological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 6e8e32a4-7b6e-4e95-a171-37484c51018b
Public Version Date: August 09, 2021
Public Version Number: 3
DI Record Publish Date: September 20, 2016