PAB

Product Code: PAB

Products Classified as PAB

3622

Cytomegalovirus (cmv) Dna Quantitative Assay

Total Product Life Cycle (TPLC) Devices

3622

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Consensus Standards

• Cytomegalovirus (Cmv) Dna Quantitative Assay [30536]: 21 CFR Unclassified 🔎

Pre-market Approvals for PAB

P130027	artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit	QIAGEN, INC.
P110037	COBAS AmpliPrep/COBAS TaqMan CMV Test	Roche Molecular Systems, Inc.
P160041	cobas CMV	ROCHE MOLECULAR SYSTEMS, INC.
P160044	Abbott RealTime CMV	ABBOTT MOLECULAR

Global Unique Device Identification Database

• 00884999047297: Cytomegalovirus (cmv) dna quantitative assay
• 00884999046603: Cytomegalovirus (cmv) dna quantitative assay
• 00884999045798: Cytomegalovirus (cmv) dna quantitative assay
• 00884999045781: Cytomegalovirus (cmv) dna quantitative assay
• 00884999045774: Cytomegalovirus (cmv) dna quantitative assay
• 00875197004939: Cytomegalovirus (cmv) dna quantitative assay
• 00875197004922: Cytomegalovirus (cmv) dna quantitative assay
• 00875197002584: Cytomegalovirus (cmv) dna quantitative assay
• 04053228024538: Cytomegalovirus (Cmv) Dna Quantitative Assay
• 04053228002086: Cytomegalovirus (Cmv) Dna Quantitative Assay
• 00875197006490: Cytomegalovirus (cmv) dna quantitative assay
• 00875197006421: Cytomegalovirus (cmv) dna quantitative assay
• 00884999049956: Cytomegalovirus (cmv) dna quantitative assay
• 00884999049611: Cytomegalovirus (cmv) dna quantitative assay
• 00884999049604: Cytomegalovirus (cmv) dna quantitative assay

Maude Adverse Events

ABBOTT REALTIME CMV AMPLIFICATION REAGENT	ABBOTT MOLECULAR, INC.	2019-01-10
ABBOTT REALTIME CMV AMPLIFICATION REAGENT	ABBOTT MOLECULAR, INC.	2018-10-03
ABBOTT REALTIME CMV AMPLIFICATION REAGENT	ABBOTT MOLECULAR, INC.	2018-10-02
COBAS? AMPLIPREP/COBAS? TAQMAN? CMV TEST	ROCHE MOLECULAR SYSTEMS	2017-02-22
CAP/CTM CMV TEST	ROCHE MOLECULAR SYSTEMS	2016-08-10
COBAS AMPLIPREP / COBAS TAQMAN CMV TEST US-IVD	ROCHE MOLECULAR SYSTEMS	2015-12-23
COBAS AMPLIPREP/COBAS TAGMAN CMV TEST	ROCHE DIAGNOSTICS	2015-06-01
COBAS AMPLIPREP/COBAS TAGMAN CMV TEST	ROCHE DIAGNOSTICS	2015-06-01
COBAS AMPLLIPREP / COBAS TAQMAN CMV TEST CE-IVD	ROCHE MOLECULAR SYSTEMS	2014-05-02