AccessGUDID - DEVICE: Acuitas (01812125010074)

GUDID

Device Identifier (DI) Information

Brand Name: Acuitas
Version or Model: AC043
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AC043
Company Name: Opgen, Inc.

Primary DI Number: 01812125010074
Issuing Agency: GS1
Commercial Distribution End Date: March 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 119234263 *Terms of Use

Device Description: QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.

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?
57871	Specimen processing instrument IVD	An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
JJH	Clinical Sample Concentrator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191288	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8f440cd6-32ff-4710-8727-a9090411c8e4
Public Version Date: September 16, 2022
Public Version Number: 3
DI Record Publish Date: October 25, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 301-869-9683
Email: technicalsupport@opgen.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES