AccessGUDID - DEVICE: HemosIL Liquid AT Substrate (08426950087571)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Liquid AT Substrate
Version or Model: 00020002600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00020002600
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950087571
Issuing Agency: GS1
Commercial Distribution End Date: July 10, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Liquid AT Substrate 6X2 ML

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?
56156	Antithrombin III (ATIII) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JBQ	ANTITHROMBIN III QUANTITATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062431	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 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: 6ca04726-98ad-4e9f-aa56-50cb2b9a4a35
Public Version Date: July 11, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016