Swab-N-Go Home Test COVID-19 Ag

Primary DI
08806133080849
Brand
Swab-N-Go Home Test COVID-19 Ag
Company
Boditech Med Inc.
Model
CFPT-17
Published
2023-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806133080849PrimaryGS10
18806133080846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806133080849088061330808498806133080849
1880613308084618806133080846

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), 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 intended to be used for self-testing by a layperson in the home or similar environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689062203
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806133032008ichroma ReaderFPRR001FPRR0012017-10-26
08806133010099ichroma ReaderFPRR001FPRR0012017-10-26
08806679001520ichroma™ CRPi-CHOMRA CRP-25i-CHOMRA CRP-252016-12-20
08806679002718ichroma™ iFOBCFPC-15CFPC-152016-12-20
08806133010068AFIAS-50FPRR022FPRR0222017-10-19
08806133010136ALFIS-3FPRR028FPRR0282021-12-06
08806133010242NuActorFPRR0322020-06-16
08806133080603NuActor Viral RNA Extraction kitUFPK-1UFPK-12020-06-16
08806133005262AFIAS TSH-SPAFIAS TSH-SPSMFP-572017-10-31
08806133005279AFIAS TSH-VBAFIAS TSH-VBSMFP-582017-11-06
08806133005255AFIAS iFOB with AFIAS-50CFPO-15-1CFPO-15-12017-08-22
08806133010075AFIAS-6/SP AnalyzerFPRR020-4FPRR020-42017-11-06
08806133060353Boditech TSH ControlAFIAS-TSHCLT2018-10-17
08806133070437Boditech TSH CalibratorAFIAS-TSHCAL2018-10-17
08806133010082AFIAS-6/VB AnalyzerFPRR020-5FPRR020-52017-11-06
00886133010075AFIAS-6/SP AnalyzerFPRR020-4FPRR020-42017-11-06
00880613305255AFIAS iFOB with AFIAS-50CFPO-15-1CFPO-15-12017-08-22