AccessGUDID - DEVICE: HemosIL Factor XIII Antigen (08426950358725)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Factor XIII Antigen
Version or Model: 00020201300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020201300
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950358725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Factor XIII Antigen

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?
60495	Coagulation factor XIII A subunit IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor XIII A subunit in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DBT	FACTOR XIII A, S, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 reagents 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: 2d691bea-9744-4494-a38f-e06c0585cf95
Public Version Date: July 14, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016