AccessGUDID - DEVICE: Lumipulse G BRAHMS PCT Immunoreaction Cartridges (04987270235058)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G BRAHMS PCT Immunoreaction Cartridges
Version or Model: 235058
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270235058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 710873907 *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?
58731	Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTM	Antigen, Inflammatory Response Marker, Sepsis
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
PRI	Procalcitonin Assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172713	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
Special Storage Condition, Specify: right side up with care, no vibration
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Handling Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests

Device Record Status

Public Device Record Key: a0c977c6-90d7-4208-8fec-cabe98111072
Public Version Date: October 10, 2024
Public Version Number: 5
DI Record Publish Date: April 02, 2018