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No Description
SEKISUI DIAGNOSTICS, LLC
1032
In Commercial Distribution
- 10742860100397 ()
- 00742860100390 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Acucy Influenza A&B Test Kit
SEKISUI DIAGNOSTICS, LLC
1010
In Commercial Distribution
- 00742860100376 ()
- 10742860100373 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
OSOM Ultra Flu A&B 25T Kit
SEKISUI DIAGNOSTICS, LLC
1006
In Commercial Distribution
- 00742860100222 ()
- 10742860100229 ()
1006
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
190
Not in Commercial Distribution
- 00742860001901 ()
- 10742860001908 ()
190
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Flu A & B, Immunochromatographic
POLYMEDCO, INC.
FLU22
In Commercial Distribution
- 00855574005407 ()
- Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical
Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens
HENRY SCHEIN, INC.
1126219
In Commercial Distribution
- 10304040019778 ()
- 00304040019771 ()
1126219
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Serology III Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Hepatitis B Core Antigen (HBc IgM) and IgM antibodies to Hepatitis A (HAV IgM). Serology III Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
Serology III Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10354
In Commercial Distribution
- 05055273216523 ()
SR10354
- Multiple-type blood-borne pathogen antibody/antigen IVD, control
Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
Serology II Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10353
In Commercial Distribution
- 05055273216516 ()
SR10353
- Multiple-type blood-borne pathogen antibody/antigen IVD, control
Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. Serology I Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
Serology I Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10352
In Commercial Distribution
- 05055273216509 ()
SR10352
- Multiple-type blood-borne pathogen antibody/antigen IVD, control
Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum.
Serology Negative Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
Serology Negative Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10351
In Commercial Distribution
- 05055273216493 ()
SR10351
- Multiple-type blood-borne pathogen antibody/antigen IVD, control
BD Horizon™ Anti-Human IgM (G20-127) BV605
Becton, Dickinson And Company
666661
In Commercial Distribution
- 00382906666611 ()
666661
- Interferon gamma release IVD, reagent
BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5
Becton, Dickinson And Company
666645
In Commercial Distribution
- 00382906666451 ()
666645
- Interferon gamma release IVD, reagent
Combo Veritor Reader 2 Hospital Flu Kit
BECTON, DICKINSON AND COMPANY
256070
Not in Commercial Distribution
- 00382902560708 ()
256070
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Kit Flu A+B 30 Test Physician Veritor
BECTON, DICKINSON AND COMPANY
256045
In Commercial Distribution
- 00382902560456 ()
256045
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Kit Flu A+B 30 Test Hospital Veritor
BECTON, DICKINSON AND COMPANY
256041
In Commercial Distribution
- 00382902560418 ()
256041
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Xpect Flu A&B Control 20Swab/SET
REMEL, INC.
R246003
In Commercial Distribution
- 30848838063702 ()
- 00848838063701 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Xpect Flu A&B KT/20TST
REMEL, INC.
R24600
In Commercial Distribution
- 30848838027032 ()
- 00848838027031 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens.
Alere Scarborough, Inc.
575-000
In Commercial Distribution
- 10811877010972 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B Antigens in nasal swab specimens.
Alere Scarborough, Inc.
412-000
Not in Commercial Distribution
- 10811877010873 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens
Alere Scarborough, Inc.
575-000
Not in Commercial Distribution
- 10811877010156 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical