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Alinity - 00380740167479

Alinity s Anti-HBc Release Control Kit
Abbott GmbH
06P0624
In Commercial Distribution

  • 00380740167479 ()
06P0624

  • Hepatitis B virus core total antibody IVD, control

Alinity - 00380740167462

Alinity s Anti-HBc Assay Control Kit
Abbott GmbH
06P0620
In Commercial Distribution

  • 00380740167462 ()
06P0620

  • Hepatitis B virus core total antibody IVD, control

Anti-Leb (Murine Monoclonal) Gamma-clone - 10888234001898

This reagent is used for the detection of the Leb antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004864
In Commercial Distribution

  • 10888234001898 ()
0004864

  • Anti-Le^b red blood cell grouping IVD, antibody

Anti-Jkb - 10888234000822

This reagent is used for the detection of the Jkb antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007604
In Commercial Distribution

  • 10888234000822 ()
0007604

  • Anti-Jk^b red blood cell grouping IVD, antibody

Anti-Fyb - 10888234000808

This reagent is used for the detection of the Fyb antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007594
In Commercial Distribution

  • 10888234000808 ()
0007594

  • Anti-Fy^b red blood cell grouping IVD, antibody

Anti-Kpb - 10888234000785

This reagent is used for the detection of the Kpb antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007550
In Commercial Distribution

  • 10888234000785 ()
0007550

  • Anti-Kp^b red blood cell grouping IVD, antibody

Anti-Fyb (Monoclonal) Gamma-clone - 10888234002383

Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004818
In Commercial Distribution

  • 10888234002383 ()
0004818

  • Anti-Fy^b red blood cell grouping IVD, antibody

Anti-Jkb (Monoclonal) Gamma-clone - 10888234002192

This monoclonal reagent is used for the detection of the Jkb antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004813
In Commercial Distribution

  • 10888234002192 ()
0004813

  • Anti-Jk^b red blood cell grouping IVD, antibody

Anti-Leb (LE2) - 23661562105421

Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) (GX336) - This reagent is designed to determine the presence of the blood group antigen Leb (LE2) on the surface of human red blood cells by manual tube method.
DIAGAST
210542
In Commercial Distribution

  • 23661562105421 ()
210542

  • Anti-Le^b red blood cell grouping IVD, antibody

Anti-Jkb (JK2) - 23661562105353

Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) (P3.143) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual tube method.
DIAGAST
210535
In Commercial Distribution

  • 23661562105353 ()
210535

  • Anti-Jk^b red blood cell grouping IVD, antibody

Anti-Fyb (FY2) - 23661562105322

Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) (SpA264LBg1) - This reagent is designed to determine the presence of the blood group antigen Fyb (FY2) on the surface of human red blood cells by manual tube method.
DIAGAST
210532
In Commercial Distribution

  • 23661562105322 ()
210532

  • Anti-Fy^b red blood cell grouping IVD, antibody

Seraclone® Anti-Jkb (JK2) - 07611969951796

Blood Grouping Reagent Anti-Jkb (JK2); Seraclone® Human Monoclonal (MS8); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808184100
In Commercial Distribution

  • 07611969951796 ()
808184100

  • Anti-Jk^b red blood cell grouping IVD, antibody

BIOCLONE - 10758750003396

ANTI-LEB (LE2) (MURINE MONOCLONAL) BIOCLONE 2.0
ORTHO-CLINICAL DIAGNOSTICS, INC.
715380
In Commercial Distribution

  • 10758750003396 ()
715380

  • Anti-Le^b red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Leb Blood Grouping Reagent - 10758750013111

The Anti-Leb reagent (Anti-LE2) is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904558
In Commercial Distribution

  • 10758750013111 ()


  • Anti-Le^b red blood cell grouping IVD, antibody

ALBAclone Anti-Leb - 05060242471049

Blood Grouping Reagent, ALBAclone Anti-Leb (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z217U
In Commercial Distribution

  • 05060242471049 ()


  • Anti-Le^b red blood cell grouping IVD, antibody

Validate - 00850011135495

aHBs Calibration Verification / Linearity Test kit
Lgc Clinical Diagnostics, Inc.
801mm
In Commercial Distribution

  • 00850011135495 ()


  • Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control

Influenza Virus B IgG ELISA - 00404847437966

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
Not in Commercial Distribution

  • 00404847437966 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

OSOM ULTRA PLUS FLU A&B Control Kit - 00742860100406

No Description
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution

  • 10742860100403 ()
  • 00742860100406 ()


  • Influenza A/B virus antigen IVD, control

Acucy Influenza A&B Control Kit - 00742860100383

No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution

  • 00742860100383 ()
  • 10742860100380 ()


  • Influenza A/B virus antigen IVD, control

OSOM Ultra Flu A&B Controls 5 Test - 00742860100215

OSOM Ultra Flu A&B Controls 5 Test
SEKISUI DIAGNOSTICS, LLC
1005
In Commercial Distribution

  • 00742860100215 ()
  • 10742860100212 ()
1005

  • Influenza A/B virus antigen IVD, control

OSOM Influenza Control Kit - 00742860100147

No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution

  • 00742860100147 ()
  • 10742860100144 ()
191

  • Influenza A/B virus antigen IVD, control

Revogene GBS LB - 00840733102363

The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
MERIDIAN BIOSCIENCE, INC.
410200
In Commercial Distribution

  • 00840733102363 ()
410200

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Alethia™ Group B Streptococcus - 00840733102196

The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth. The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
MERIDIAN BIOSCIENCE, INC.
480350
In Commercial Distribution

  • 00840733102196 ()
480350

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

illumigene Group B Streptococcus - 00840733101342

The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth. The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.
MERIDIAN BIOSCIENCE, INC.
280350
Not in Commercial Distribution

  • 00840733101342 ()
280350

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

BinaxNOW Influenza A & B Card 2 Control Swab Kit - 10811877010989

Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
Alere Scarborough, Inc.
575-080
In Commercial Distribution

  • 10811877010989 ()


  • Influenza A/B virus antigen IVD, control

Alere Influenza A & B Control Swab Kit - 10811877010880

The Control Swabs are intended for use only with the Alere Influenza A & B Test.
Alere Scarborough, Inc.
412-080
Not in Commercial Distribution

  • 10811877010880 ()


  • Influenza A/B virus antigen IVD, control

Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit - 10811877010194

Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
Alere Scarborough, Inc.
575-080
Not in Commercial Distribution

  • 10811877010194 ()


  • Influenza A/B virus antigen IVD, control

Influenza Virus B IgG ELISA - 00840239037961

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ARIES® GBS Assay - 00840487100165

The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
LUMINEX CORPORATION
50-10021
Not in Commercial Distribution

  • 00840487100165 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

VITROS - 10758750001200

VITROS Immunodiagnostic Products Anti-HBc IgM Controls
ORTHO CLINICAL DIAGNOSTICS
6801427
In Commercial Distribution

  • 10758750001200 ()
  • 20758750001207 ()
6801427

  • Hepatitis B virus surface immunoglobulin M (IgM) antibody IVD, control

CHORUS INFLUENZA B IgG - 08033891327538

No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

LIAISON® XL MUREX Anti-HBc - 08056771103367

No Description
DIASORIN SPA
318130
In Commercial Distribution

  • 08056771103367 ()
  • 18056771103364 ()


  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

ETI-AB-AUK PLUS - 08056771102360

No Description
DIASORIN SPA
P001931
In Commercial Distribution

  • 08056771102360 ()


  • Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)

ETI-AB-EBK PLUS - 08056771102346

No Description
DIASORIN SPA
P001929
In Commercial Distribution

  • 08056771102346 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, enzyme immunoassay (EIA)

Influenza B IgG ELISA Test Kit - B350GSD0130100

Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

RAMP® Flu A + B Control Swabs - 10627966005190

No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control

Drew Scientific - 00817274020210

DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL)
DREW SCIENTIFIC, INC.
014-380SA
In Commercial Distribution

  • 00817274020210 ()


  • Hepatitis B virus e-antigen total antibody IVD, calibrator

Drew Scientific - 00817274020203

DS5 HbA1c Calibrator (4x 0.5mL L1, 4x 0.5mL L2, 1x 6mL Diluent)
DREW SCIENTIFIC, INC.
014-380
In Commercial Distribution

  • 00817274020203 ()


  • Hepatitis B virus e-antigen total antibody IVD, calibrator

Influenza A & B Virus Antigen Control Slide, 4 wells - B110QAB15040

No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution

  • B110QAB15040 ()
QAB-1504

  • Influenza A/B virus antigen IVD, control

Group B Strep Assay - B178GBGBS100

No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution

  • B178GBGBS100 ()
  • B178GBGBS102 ()
GBGBS-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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