AccessGUDID - DEVICE: INNO-LiPA HCV 2.0 Amp (05414470816637)

GUDID

Device Identifier (DI) Information

Brand Name: INNO-LiPA HCV 2.0 Amp
Version or Model: 81663
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fujirebio Europe

Primary DI Number: 05414470816637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 297346645 *Terms of Use

Device Description: No description.

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?
59866	Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the genotype determination of Hepatitis C virus in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBF	Assay, Genotyping, Hepatitis C Virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160016	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
Storage Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Number of tests per kit = 100

Device Record Status

Public Device Record Key: d1f9da85-a01b-45ca-af5d-ff54f3f52108
Public Version Date: June 09, 2025
Public Version Number: 1
DI Record Publish Date: May 30, 2025

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +32093291329
Email: info@fujirebio.com

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