Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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1126 -1.000 EACH GG 2 Shelf Cabinet Emp w/Pkt 62730 -1.000 EACH Woven Knuckle 8s 6507 -1.000 EACH GG Hydrocortisone Unit (10) 62612 -1.000 EACH Fingertip Woven M/L 10s 6314 -1.000 EACH GG 1x3 Plastic Strip Bndg (60) 6253 -1.000 EACH Waterproof Tape 1/2" x 5yds 6206 -1.000 EACH GG 3x3 Gauze Pads (25) 4105 -1.000 EACH GG 4oz Eye Wash 2209 - 1.000 EACH Pain & Ache relief (100) 6400 -2.000 EACH GG Triangular Bandage + 6213 -4.000 EACH 5x9 Combine Dressing ABD 3004 -1.000 EACH GG Hydrogen Peroxide 2oz pump 3002 -1.000 EACH GG Derma Cool (2 oz.) 1125PI- 1.000 EACH Pocket Items 2 shelf Kit 3302 -2.000 EACH GG Cold Pack Medium/Boxed + 66002 -1.000 EACH Latex Free Tourniquet 76001 -1.000 EACH Multi-Purpose Splint Folded 6112 -2.000 EACH 2" Stretch Roller Gauze NS 6114 -1.000 EACH 4" Stretch Roller Gauze 3106 -1.000 EACH GG Derma-Caine Burn Cream (25) 3101 -1.000 EACH GG Tri-Antibiotic Ointment (25) 3025 -2.000 U GG Antiseptic Towelettes (25) 80201 -1.000 EACH CPR Mask 3160 -2.000 EACH WJ Burn Dressing 4x4 6252- 1.000 EACH Tape 1/2" X 2 1/2 Y ANSI-B -1.000 EACH ANSI STICKER B
Greenguard
1125
In Commercial Distribution

  • 50347682011258 ()
  • 00347682011253 ()
1125

  • First aid kit, medicated
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-20T
In Commercial Distribution

  • 00855402007979 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-5T
In Commercial Distribution

  • 00855402007962 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-2T
In Commercial Distribution

  • 00855402007955 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
LUMIQUICK DIAGNOSTICS, INC.
1N40C5-1-US-BS
In Commercial Distribution

  • 00855636003723 ()
  • 00855636003716 ()
  • 00855636003730 ()
  • 00855636003747 ()
  • 00855636003754 ()
  • 00855636003761 ()
  • 00855636003778 ()
  • 00855636003785 ()
1N40C5-1-US-BS

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution

  • 00860002028095 ()


  • Oral/upper respiratory tract specimen collection kit IVD, home-use
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Coach's First Aid Kit- (15) Adhesive Plastic Bandages 3/4" x 3", (20) Junior Adhesive Plastic Bandages 3/8" x 1-1/2", (3) Adhesive Plastic Bandages 1" x 3", (15) Adhesive Spot Bandages 7/8"x7/8", (1) Knuckle Fabric Bandage, (1) Fingertip Fabric Bandage, (1) Elbow/Knee Adhesive Bandage, (2) Butterfly Wound Closures, (1) Triangular Bandage 4"x 4"x 5", (2) Sterile Gauze Pads 2"x2", (1) Pressure Bandage 2"x 2", (1) Pressure Bandage 3"x 3", (1) First Aid Tape Roll 1/2"x2.5yds, (1) Instant Ice Pack, (2) Alcohol Cleansing Pads, (4) Antiseptic Towelettes, (1) CPR Breathing Barrier, (1) Emergency First Aid Guide, (6) Assorted Safety Pins, (2) Medical Grade Vinyl Gloves, (1) Burn Cream, (1) Triple Antibiotic Ointment 0.9g, (10) Cotton Tipped Applicators, (1) Blood Stopper Dressing, (1) Sterile Eye Pad, (1) Sterile Eye Wash 10ml, (2) Chewable Aspirin Tablets
CRAMER PRODUCTS, INC.
761206
In Commercial Distribution

  • 00311960743075 ()


  • First aid kit, non-medicated, single-use
The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58961
In Commercial Distribution

  • 15099590738648 ()
C58961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate). The Access SARS-CoV-2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgM should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgM assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58957
In Commercial Distribution

  • 15099590738617 ()
C58957

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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