AccessGUDID - DEVICE: HemosIL FII & FV DNA Control (08426950453086)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL FII & FV DNA Control
Version or Model: 00020003500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00020003500
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950453086
Issuing Agency: GS1
Commercial Distribution End Date: December 29, 2023
Device Count: 3
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL FII & FV DNA Control

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:	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?
59585	Inherited thrombophilia IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZB	Quality control material, genetics, dna

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093737	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
Special Storage Condition, Specify: Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
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: e95a0faa-3ecd-4896-9581-b7ce9de522ef
Public Version Date: January 01, 2024
Public Version Number: 8
DI Record Publish Date: September 23, 2016