AccessGUDID - DEVICE: LEFLUNOMIDE V2 LOW LEVEL 1 (B800LEFLUV2LL10)

GUDID

Device Identifier (DI) Information

Brand Name: LEFLUNOMIDE V2 LOW LEVEL 1
Version or Model: LEFLU V2 L L1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LEFLU V2 L L1
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B800LEFLUV2LL10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: LEFLUNOMIDE V2 LOW LEVEL 1

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):	No
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?
47869	Multiple-type clinical chemistry analyte profile IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: more than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: .5 Milliliter

Device Record Status

Public Device Record Key: d4c82507-d8c7-469d-b62a-ec6fe250a570
Public Version Date: October 02, 2023
Public Version Number: 1
DI Record Publish Date: September 22, 2023