AccessGUDID - DEVICE: Pointe Scientific, Inc. (00811727013330)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientific, Inc.
Version or Model: P1035-96
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1035-96
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727013330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 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?
58946	Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DGC	Ige, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992528	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: 6eb44cf9-128f-420e-b66a-e3cdcbb60e03
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: August 31, 2016