AccessGUDID - DEVICE: Pointe Scientific, Inc. CMV IgG (00811727015198)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientific, Inc. CMV IgG
Version or Model: T8005-96
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T8005-96
Company Name: HORIBA INSTRUMENTS INCORPORATED

Primary DI Number: 00811727015198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052845583 *Terms of Use

Device Description: Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

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:	Yes
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?
49712	Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954191	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b1111db-b6c6-481d-af63-38f7c8de8b8b
Public Version Date: October 02, 2025
Public Version Number: 4
DI Record Publish Date: August 31, 2016