AccessGUDID - DEVICE: K-ASSAY® Apo B Reagent (L) (00816426020177)

GUDID

Device Identifier (DI) Information

Brand Name: K-ASSAY® Apo B Reagent (L)
Version or Model: KAI-024
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KAI-024
Company Name: KAMIYA BIOMEDICAL COMPANY, LLC

Primary DI Number: 00816426020177
Issuing Agency: GS1
Commercial Distribution End Date: November 22, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 197934250 *Terms of Use

Device Description: For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.

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?
53448	Apolipoprotein B (Apo B) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of apolipoprotein B (Apo B) lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993354	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: efd16244-8f9b-48e2-a025-44d16c212153
Public Version Date: November 23, 2023
Public Version Number: 4
DI Record Publish Date: September 16, 2016