FDA.reportPublic FDA data

Smart DetectTM SARS-CoV-2 rRT-PCR Kit

Primary DI
B379COV2E0
Brand
Smart DetectTM SARS-CoV-2 rRT-PCR Kit
Company
INBIOS INTERNATIONAL, INC
Model
COV2-E
Device description
EUA
Published
2020-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJRReagents, 2019-Novel Coronavirus Nucleic AcidUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B379COV2E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004006628
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestCOVG-RE2022-12-08
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestRCFP-25RCFP-252025-10-06
B379RCFPCK101COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (10 sets)RCFP-CK102025-10-06
B379RCFPCK21COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (1 set)RCFP-CK22025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-2RCFS-22025-10-06
B379RCFS41COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-4RCFS-42025-10-06
B379COVAF201SCoV-2 Ag Detect™ Rapid TestCOVAF-202024-09-13
B379COVAF501SCoV-2 Ag Detect™ Rapid TestCOVAF-502024-09-13
B379STNG11Strongy DetectTM IgG ELISASTNG-12024-09-13
B379ZKM21ZIKV Detect™ 2.0 IgM Capture ELISAIVD2019-05-24
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISACOVN-E2022-12-08
B379C19S21COVID-19 Detect™ Rapid Self -TestC19S-22026-01-16
B379RCFPCK201COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)RCFP-CK202025-10-06
B379AAP11Active Anthrax Detect Plus Rapid TestAAP-12023-03-03
B379CAGS21SCoV-2 Ag Detect™ Rapid Self-TestCAGS-22022-12-08
B379COVAGRC1SCoV-2 Ag Detect™ Rapid TestCOVAG-RC2022-12-08
B379COVEG1SCoV-2 Detect™ IgG ELISACOVE-G2022-12-08
B379COVEM1SCoV-2 Detect™ IgM ELISACOVE-M2022-12-08
B379CL0251CL Detect Rapid Test for Cutaneous LeishmaniasisCL025CL0252018-09-24
B379CP0501Chagas Detect™ Plus Rapid TestCP050CP0502018-09-24

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Primary DI, Brand, Company table
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