AccessGUDID - DEVICE: IDG/Sanzay (00850053916212)

GUDID

Device Identifier (DI) Information

Brand Name: IDG/Sanzay
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HCC1
Company Name: IDG/SANZAY Corporation

Primary DI Number: 00850053916212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948875013 *Terms of Use

Device Description: The IDG Control Level 1 Normal is intended for use in quality assurance of in vitro diagnostic coagulation tests (1-3). The reagent is suitable for use as a normal coagulation time control in the one-stage prothrombin time (PT) assay and in the activated partial thromboplastin time (APTT) 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):	No
Over the Counter (OTC):	Yes
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?
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGN	Plasma, Coagulation Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022046	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: 64997c9e-7922-4ee4-8607-6badfbafb309
Public Version Date: January 22, 2024
Public Version Number: 1
DI Record Publish Date: January 12, 2024