Abbott-Molecular-Inc

PMA#

• Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit

  2022-04-11

  Abbott Molecular Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP170005 Supplement NumberS004 Date Received03/10/2022 Decision Date04/11/2022 Product Code OWD  Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Process Ch...

• Abbott RealTime IDH2

  2021-03-03

  Abbott Molecular Inc.

• Abbott RealTime IDH2

  2021-01-19

  Abbott Molecular Inc.

• RealTime IDH2

  2019-09-24

  Abbott Molecular Inc.

• Abbott RealTime IDH2

  2017-08-01

  Abbott Molecular Inc.

GUDID#

• Alinity m - Alinity m HR HPV Application Specification File

  ABBOTT MOLECULAR INC.

  2026-07-27

• Alinity m - Specimen Collection Swab

  ABBOTT MOLECULAR INC.

  2026-07-06

• RealTime - Specimen Collection Swab

  ABBOTT MOLECULAR INC.

  2026-07-06

• simpli-COLLECT - simpli-COLLECT HPV Collection Kit

  ABBOTT MOLECULAR INC.

  2026-04-13

• Alinity m - Alinity m HR HPV Application Specification File

  ABBOTT MOLECULAR INC.

  2026-04-13

• Alinity m - Alinity m HSV 1 & 2 / VZV Application Specification File v2.0

  ABBOTT MOLECULAR INC.

  2025-11-20

• Alinity m - Alinity m Integrated Reaction Units

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m Pipette Tips, 1000uL

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Allinity m Pipette Tips, 50uL

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m IRU Waste Container

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m Sample Rack Holder

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m CO-RE Tip Sleeve

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m Universal Sample Rack

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m Assay Tray Carrier

  ABBOTT MOLECULAR INC.

  2020-04-29

• Alinity m - Alinity m Waste Box

  ABBOTT MOLECULAR INC.

  2020-04-29

• m2000 - m2000rt Instrument System

  ABBOTT MOLECULAR INC.

  2016-09-01

• Alinity m - Alinity m System

  ABBOTT MOLECULAR INC.

  2020-08-18

• Alinity m - Alinity m Resp-4-Plex Application Specification File

  ABBOTT MOLECULAR INC.

  2025-06-27

• Alinity m - Alinity m Resp-4-Plex CTRL Kit

  ABBOTT MOLECULAR INC.

  2025-06-27

• Alinity m - Alinity m Resp 4 Plex AMP Kit

  ABBOTT MOLECULAR INC.

  2025-06-27

• simpli-COLLECT - simpli-COLLECT Urine Collection Kit

  ABBOTT MOLECULAR INC.

  2025-06-26

• simpli-COLLECT - simpli-COLLECT Swab Collection Kit

  ABBOTT MOLECULAR INC.

  2025-06-26

• simpli-COLLECT - simpli-COLLECT Urine Collection Kit

  ABBOTT MOLECULAR INC.

  2025-06-26

• simpli-COLLECT - simpli-COLLECT Swab Collection Kit

  ABBOTT MOLECULAR INC.

  2025-06-26

• Alinity m - Alinity m BKV Application Specification File

  ABBOTT MOLECULAR INC.

  2025-05-30

• Alinity m - Alinity m BKV AMP Kit

  ABBOTT MOLECULAR INC.

  2025-05-30

• Alinity m - Alinity m BKV CTRL Kit

  ABBOTT MOLECULAR INC.

  2025-05-30

• Alinity m - Alinity m BKV CAL Kit

  ABBOTT MOLECULAR INC.

  2025-05-30

• Alinity mp - Alinity mp Well Plate

  ABBOTT MOLECULAR INC.

  2025-05-28

• Alinity mp - Alinity mp Well Plate Input Rack

  ABBOTT MOLECULAR INC.

  2025-05-28

• Alinity mp - Alinity mp Tube Input Rack

  ABBOTT MOLECULAR INC.

  2025-05-28

• Alinity mp - Alinity mp Reagent Addition Assembly

  ABBOTT MOLECULAR INC.

  2025-05-28

• Alinity mp - Alinity mp Well Plate

  ABBOTT MOLECULAR INC.

  2025-05-28

• Vysis - Vysis CEP 17 (D17Z1) (satellite) SpectrumGreen Probe

  ABBOTT MOLECULAR INC.

  2017-12-15

• Vysis - Vysis TelVysion Xp/Yp SpectrumGreen Probe

  ABBOTT MOLECULAR INC.

  2017-12-15

• Alinity m - Alinity m HCV Application Specification File

  ABBOTT MOLECULAR INC.

  2020-05-04

• Alinity m - Alinity m SARS-CoV-2 Application Specification File

  ABBOTT MOLECULAR INC.

  2020-05-08

• Alinity m - Alinity m HIV-1 Application Specification File

  ABBOTT MOLECULAR INC.

  2020-09-09

• Alinity m - Alinity m HBV Application Specification File

  ABBOTT MOLECULAR INC.

  2020-09-23

• Alinity m - Alinity m HBV CAL Kit

  ABBOTT MOLECULAR INC.

  2020-09-23

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