AccessGUDID - DEVICE: HemosIL Low Fibrinogen Control (08426950451976)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Low Fibrinogen Control
Version or Model: 00020004200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020004200
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950451976
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Low Fibrinogen 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?
32393	Fibrinogen assay (factor I) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQJ	System, Fibrinogen Determination

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7591c44-a7b8-47c4-9eb0-a0752ad88e33
Public Version Date: July 14, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016