AccessGUDID - DEVICE: RedLine Alert™ Test (G143TC51230101)

GUDID

Device Identifier (DI) Information

Brand Name: RedLine Alert™ Test
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC-5123-010
Company Name: Tetracore, Inc.

Primary DI Number: G143TC51230101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 070893032 *Terms of Use

Device Description: Immunochromatographic test kit for presumptive identification of Bacillus anthracis colonies

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?
50428	Bacillus anthracis antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Bacillus anthracis 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 to detect Bacillus anthracis, the bacteria associated with anthrax. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPO	Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030370	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e5cc028a-847e-46ef-81ae-0a561a285fec
Public Version Date: April 07, 2023
Public Version Number: 2
DI Record Publish Date: June 15, 2022