AccessGUDID - DEVICE: Antithrombin III RID plate package (B1761485)

GUDID

Device Identifier (DI) Information

Brand Name: Antithrombin III RID plate package
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 148511
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761485
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093642254 *Terms of Use

Device Description: Radial immunodiffusion plate package for Human Antithrombin III with standards

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):	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?
61983	Antithrombin III (ATIII) IVD, kit, precipitation/immunodiffusion	A collection of reagents and other associated materials intended to be used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen, using a precipitation/immunodiffusion method. ATIII inhibits coagulation and its deficiency is a result of a rare hereditary disorder, which increases the risk of thrombosis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JBQ	Antithrombin Iii Quantitation

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: d752a5a6-202e-4041-a78f-b73aca811db4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016