AccessGUDID - DEVICE: CRYOcheck Chromogenic Factor IX (00843876000565)

GUDID

Device Identifier (DI) Information

Brand Name: CRYOcheck Chromogenic Factor IX
Version or Model: CCCF09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCCF09
Company Name: Precision Biologic Inc

Primary DI Number: 00843876000565
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 244713368 *Terms of Use

Device Description: CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use

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?
56249	Coagulation factor IX IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative detection of coagulation factor IX in a clinical specimen, using a chromogenic method. Factor IX deficiency may result in a hereditary bleeding disorder known as haemophilia B or Christmas disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGP	Test, Qualitative And Quantitative Factor Deficiency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214002	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: less than -70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c905a33-2dc0-4dd4-89f3-f316c00c4f65
Public Version Date: January 16, 2023
Public Version Number: 1
DI Record Publish Date: January 06, 2023