AccessGUDID - DEVICE: VIDAS® B·R·A·H·M·S PCT ™ (03573026223601)

GUDID

Device Identifier (DI) Information

Brand Name: VIDAS® B·R·A·H·M·S PCT ™
Version or Model: 30450-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026223601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: VIDAS ® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the VIDAS ® instruments for the determination of procalcitonin in human serum or plasma.

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?
61534	Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of procalcitonin (PCT) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a marker of bacterial sepsis or severe bacterial infection.	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 [?]
K071146	000
K160911	000
K162827	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eae7fa54-29ea-4d48-96b0-146e0a7c8b4d
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: September 23, 2016