AccessGUDID - DEVICE: Nano-CheckTM PCT plus (00895160002441)

GUDID

Device Identifier (DI) Information

Brand Name: Nano-CheckTM PCT plus
Version or Model: CD7156
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD7156
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 126544316 *Terms of Use

Device Description: In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, serum and 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:	Yes
Prescription Use (Rx):	No
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?
58305	Procalcitonin (PCT) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended for the qualitative and/or (semi-)quantitative detection of procalcitonin (PCT) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTM	Antigen, Inflammatory Response Marker, Sepsis

FDA Premarket Submission

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

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65af3537-84df-498c-baee-ba88a3956a52
Public Version Date: June 29, 2023
Public Version Number: 4
DI Record Publish Date: September 12, 2016