Rapid Response

GUDID 10722066005115

COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)

BTNX Inc

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10722066005115
NIH Device Record Keyd25bc97e-0a00-4b14-9c3c-3c4a13186d62
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapid Response
Version Model NumberCOV-13C25
Company DUNS251005005
Company NameBTNX Inc
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100722066005118 [Unit of Use]
GS110722066005115 [Primary]

FDA Product Code

QKOReagent, Coronavirus Serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-20
Device Publish Date2020-03-23

On-Brand Devices [Rapid Response]

00722066004562D12.11-1VA
00722066004548D12.5-1V
00722066004524D5.1-1V
00722066004364Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are
00722066003701Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/B
00722066003695Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 T
00722066003688Rapid Response Multi Drug Test Panel (Amphetamine, Barbiturate, Buprenorphine, Benzodiazepine, M
00722066003671Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 te
00722066003664Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/PCP/BAR/BZO/BUP) - 25 tests/
00722066003657Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/BUP) - 25 tests/ kit
00722066003640Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative deter
00722066003541Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tes
00722066003459Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitat
00722066003428Rapid Response Multi Drug Test Panels (AMP/COC/THC) - 25 tests/ kit are for the qualitative dete
00722066003404Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitri
00722066003343Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of
00722066003312Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit
00722066003244Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detection of H
00722066003107Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TC
00722066003022Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) -
00722066001974Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative
00722066001905Rapid Response Adenovirus Test Cassettes - 20 tests/ kit are for the qualitative detection of va
00722066001899Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavir
00722066001882Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of hu
00722066001646Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitativ
00722066001202Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative detection of Hu
00722066001172Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) -
00722066001042Rapid Response hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative detection of Hum
00722066000915Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PCP/BAR/BZO/MTD/MD
00722066000908Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC
00722066000892Rapid Response Multi Drug Integrated Split Specimen Cups (COC,AMP,MET,THC,OPI,BZO) - 25 tests/ k
00722066000885Rapid Response Multi Drug Integrated Split Specimen Cup (COC/MET/THC/OPI/PCP) - 25 tests/ kit ar
00722066000847Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit a
00722066000830Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/OPI/BZO) - 25 tests/ kit are for qualitat
00722066000809Rapid Response Multi Drug Test Panels (COC/AMP/MET/OPI/THC) - 25 tests/ kit are for the qualitat
00722066000793Rapid Response Multi Drug Test Panels (COC/THC/AMP/OPI) - 25 tests/ kit are for the qualitative
00722066000786Rapid Response Multi Drug Test Panels (MET/COC/THC) - 25 tests/ kit are for the qualitative dete
00722066000779Rapid Response Multi Drug Test Panels (THC/COC/OPI) - 25 tests/ kit are for the qualitative dete
00722066000762Rapid Response Multi Drug Test Panels (COC/THC) are for the qualitative detection of Cocaine and
00722066000731Rapid Response Single Drug Test Cassette (THC) - 40 tests/ kit are for the qualitative detection
00722066000724Rapid Response Single Drug Test Strips (THC) - 100 tests/ kit are for the qualitative detection
00722066000670Rapid Response Single Drug Test Cassettes (PCP) - 40 tests/ kit are for the qualitative detectio
00722066000663Rapid Response Single Drug Test Strips (PCP) - 100 tests/ kit are for the qualitative detection
00722066000618Rapid Response Single Drug Test Cassette (OPI) - 40 tests/ kit are for the qualitative detection
00722066000601Rapid Response Single Drug Test Strips (OPI) - 100 tests/ kit are for the qualitative detection
00722066000557Rapid Response Single Drug Test Cassettes (MDMA) - 40 tests/ kit are for qualitative detection o
00722066000540Rapid Response Single Drug Test Strips (MDMA) - 100 tests/ kit are for the qualitative detection
00722066000533Rapid Response Single Drug Test Cassettes (COC) - 40 tests/ kit are for the qualitative detectio
00722066000526Rapid Response Single Drug Test Strips (COC) - 100 tests/ kit are for the qualitative detection
00722066000519Rapid Response Single Drug Test Cassettes (BZO) - 40 tests/ kit are for the qualitative detectio

Trademark Results [Rapid Response]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAPID RESPONSE
RAPID RESPONSE
98874073 not registered Live/Pending
Bensuaski, Giana
2024-11-26
RAPID RESPONSE
RAPID RESPONSE
98873235 not registered Live/Pending
Enerfab Process Solutions, LLC
2024-11-26
RAPID RESPONSE
RAPID RESPONSE
98501114 not registered Live/Pending
Cloyd, Rebecca K.
2024-04-15
RAPID RESPONSE
RAPID RESPONSE
98110554 not registered Live/Pending
Silver Technologies, LLC
2023-07-31
RAPID RESPONSE
RAPID RESPONSE
97035529 not registered Live/Pending
Medline Industries, LP
2021-09-20
RAPID RESPONSE
RAPID RESPONSE
90510816 not registered Live/Pending
BTNX Inc.
2021-02-04
RAPID RESPONSE
RAPID RESPONSE
90185483 not registered Live/Pending
Workplace Options, LLC
2020-09-16
RAPID RESPONSE
RAPID RESPONSE
90084039 not registered Live/Pending
Fastaff, LLC
2020-07-30
RAPID RESPONSE
RAPID RESPONSE
87434666 not registered Dead/Abandoned
MW Industries, Inc.
2017-05-03
RAPID RESPONSE
RAPID RESPONSE
87399877 5489475 Live/Registered
Optensity, Inc.
2017-04-05
RAPID RESPONSE
RAPID RESPONSE
86730832 4927265 Live/Registered
Biolife, L.L.C.
2015-08-20
RAPID RESPONSE
RAPID RESPONSE
86140853 4779131 Live/Registered
Fastaff, LLC
2013-12-11

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