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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 Size Device Size Type Device Class Implantable

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QuantiFERON®-TB Gold Plus - 14053228033568

QFT-Plus Blood Collection Tubes (1200x)
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228033568 ()
622529

  • Interferon gamma release IVD, reagent

QuantiFERON-TB Gold Blood Collection Tubes - High Altitude - 14053228002151

bulk pack
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002151 ()
  • 04053228002154 ()
T05900505

  • Interferon gamma release IVD, reagent

QuantiFERON-TB Gold Blood Collection Tubes - 14053228002144

Bulk pack
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002144 ()
  • 04053228002147 ()
T05900301

  • Interferon gamma release IVD, reagent

QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude - 14053228002137

No Description
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002137 ()
  • 04053228002130 ()
5970405

  • Interferon gamma release IVD, reagent

QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - 14053228002120

QF-TB Gold Blood collection tubes - Dispenser Pack (25 single patient packs)
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002120 ()
  • 04053228002123 ()
5970403

  • Interferon gamma release IVD, reagent

SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +) - 05055273216523

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 (SEROLOGY II CONTROL +) - 05055273216516

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 POSITIVE CONTROL (SEROLOGY I CONTROL +) - 05055273216509

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 (SEROLOGY CONTROL -) - 05055273216493

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

Remel - 00848838063701

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
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