AccessGUDID - DEVICE: ACL TOP 370 (00195226000566)

GUDID

Device Identifier (DI) Information

Brand Name: ACL TOP 370
Version or Model: 00000280067
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00000280067
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 00195226000566
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: ACL TOP 370

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?
56689	Coagulation analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKP	Instrument, Coagulation, Automated

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6bf2f7ae-ce6e-4d42-a7dc-4b94b547d238
Public Version Date: May 23, 2024
Public Version Number: 1
DI Record Publish Date: May 15, 2024