RedLine Alert™ Test

Primary DI
G143TC51230101
Brand
RedLine Alert™ Test
Company
Tetracore, Inc.
Model
N/A
Catalog number
TC-5123-010
Device description
Immunochromatographic test kit for presumptive identification of Bacillus anthracis colonies
Published
2022-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NPOKit, Immunochromatographic, Bacillus Anthracis Differential Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPOKit, Immunochromatographic, Bacillus Anthracis Differential AntibodyMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030370000REDLINE ANTHRAX ALERT TESTTetracore, Inc.2003-12-09NPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G143TC51230101PrimaryHIBCC0
G143TC51230100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bacillus anthracis antigen IVD, kit, rapid ICT, clinicalA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070893032
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true