AccessGUDID - DEVICE: HemosIL AcuStar Anti-B2 Glycoprotein-I IgG (08426950496977)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL AcuStar Anti-B2 Glycoprotein-I IgG
Version or Model: 0009802012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0009802012
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950496977
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL AcuStar Anti-B2 Glycoprotein-I IgG

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?
54874	Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSV	System,test,antibodies,b2 - glycoprotein i (b2 - gpi)

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 reagents and calibrators are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a6ec937e-4975-4f50-806f-60dd14af0eff
Public Version Date: October 23, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2016