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Establishment Registration & Device Listing

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6 to 10 of 11 Results for Product Code : MAQ

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Establishment
Name

Registration Number

Current
Registration Yr

QIAGEN

MD/USA

1122376

2026

kit, dna detection, human papillomavirus - digene® HPV Genotyping PS Test

U.S. Manufacturer of Export Only Devices

kit, dna detection, human papillomavirus - digene® HC2 High-Risk HPV DNA Test; digene® HC2 HPV DNA Test; DML 3000

Manufacturer; Specification Developer

ROCHE DIAGNOSTICS GMBH

GERMANY

9610126

2026

kit, dna detection, human papillomavirus - cobas 4800 HPV Amplification/Detection Kit, 240 Tests; cobas 4800 HPV Amplification/Detection Kit, 960 Tests; cobas 4800 HPV Controls Kit, 10 Sets; cobas 4800 System cobas HPV AP software; cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests; cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests; cobas 4800 System Sample Preparation Kit, 240 Tests; cobas 4800 System Sample Preparation Kit, 960 Tests; cobas 4800 System Wash Buffer Kit, 240 Tests; cobas 4800 System Wash Buffer Kit, 960 Tests; cobas HPV Test; cobas Sample Prep Buffer; cobas x480 system; cobas z480 Analyzer; cobas z480 system; KIT cobas 4800 HPV AMP/DET 240T US-IVD; KIT cobas 4800 HPV AMP/DET 960T US-IVD; KIT cobas 4800 HPV CONTROLS 10 SETS IVD; KIT cobas 4800 SYS LIQ CYT PREP 240T IVD; KIT cobas 4800 SYS LIQ CYT PREP 960T IVD; KIT cobas 4800 SYS SAMPLE PREP 240T IVD; KIT cobas 4800 SYS SAMPLE PREP 960T IVD; KIT cobas 4800 SYS WASH BUFFER 240T IVD; KIT cobas 4800 SYS WASH BUFFER 960T IVD; KIT COBAS SAMPLE PREP BUFFER 480T IVD; SW C4800 HPV AP v2.1.0 CD; SW COBAS 4800 FSE TOOLS CD 3.0; SW cobas 4800 UDF v2.0.0 CD; SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD

Foreign Exporter

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

SWITZERLAND

3003795116

2026

kit, dna detection, human papillomavirus - cobas 4800 HPV Amplification/Detection Kit, 240 Tests; cobas 4800 HPV Amplification/Detection Kit, 960 Tests; cobas 4800 HPV Controls Kit, 10 Sets; cobas 4800 System cobas HPV AP software; cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests; cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests; cobas 4800 System Sample Preparation Kit, 240 Tests; cobas 4800 System Sample Preparation Kit, 960 Tests; cobas 4800 System Wash Buffer Kit, 240 Tests; cobas 4800 System Wash Buffer Kit, 960 Tests; cobas HPV Test; cobas Sample Prep Buffer; cobas x480 system; cobas z480 Analyzer; cobas z480 system; KIT cobas 4800 HPV AMP/DET 240T US-IVD; KIT cobas 4800 HPV AMP/DET 960T US-IVD; KIT cobas 4800 HPV CONTROLS 10 SETS IVD; KIT cobas 4800 SYS LIQ CYT PREP 240T IVD; KIT cobas 4800 SYS LIQ CYT PREP 960T IVD; KIT cobas 4800 SYS SAMPLE PREP 240T IVD; KIT cobas 4800 SYS SAMPLE PREP 960T IVD; KIT cobas 4800 SYS WASH BUFFER 240T IVD; KIT cobas 4800 SYS WASH BUFFER 960T IVD; KIT COBAS SAMPLE PREP BUFFER 480T IVD; SW C4800 HPV AP v2.1.0 CD; SW COBAS 4800 FSE TOOLS CD 3.0; SW cobas 4800 UDF v2.0.0 CD; SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD

Manufacturer

ROCHE MOLECULAR SYSTEMS, INC.

NJ/USA

2243471

2026

kit, dna detection, human papillomavirus - KIT COBAS 58/68/8800 HPV 480T IVD; KIT COBAS 58/68/8800 HPV RMC IVD; KIT COBAS 6800/8800 BUFF NEG RMC IVD; KIT COBAS 6800/8800 HPV 480T IVD; KIT COBAS 6800/8800 HPV RMC IVD

Manufacturer

kit, dna detection, human papillomavirus - cobas 4800 HPV Amplification/Detection Kit, 240 Tests; cobas 4800 HPV Amplification/Detection Kit, 960 Tests; cobas 4800 HPV Controls Kit, 10 Sets; cobas 4800 System cobas HPV AP software; cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests; cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests; cobas 4800 System Sample Preparation Kit, 240 Tests; cobas 4800 System Sample Preparation Kit, 960 Tests; cobas 4800 System Wash Buffer Kit, 240 Tests; cobas 4800 System Wash Buffer Kit, 960 Tests; cobas HPV Test; cobas Sample Prep Buffer; cobas x480 system; cobas z480 Analyzer; cobas z480 system; KIT cobas 4800 HPV AMP/DET 240T US-IVD; KIT cobas 4800 HPV AMP/DET 960T US-IVD; KIT cobas 4800 HPV CONTROLS 10 SETS IVD; KIT cobas 4800 SYS LIQ CYT PREP 240T IVD; KIT cobas 4800 SYS LIQ CYT PREP 960T IVD; KIT cobas 4800 SYS SAMPLE PREP 240T IVD; KIT cobas 4800 SYS SAMPLE PREP 960T IVD; KIT cobas 4800 SYS WASH BUFFER 240T IVD; KIT cobas 4800 SYS WASH BUFFER 960T IVD; KIT COBAS SAMPLE PREP BUFFER 480T IVD; SW C4800 HPV AP v2.1.0 CD; SW COBAS 4800 FSE TOOLS CD 3.0; SW cobas 4800 UDF v2.0.0 CD; SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD

Manufacturer

kit, dna detection, human papillomavirus - INFORM HPV II Family 6 Probe; INFORM HPV III Family 16 Probe (B); KIT cobas 4800 HPV AMP/DET 240T CE-IVD; KIT cobas 4800 HPV AMP/DET 960T CE-IVD

U.S. Manufacturer of Export Only Devices

ROCHE MOLECULAR SYSTEMS, INC.

CA/USA

3004141078

2026

kit, dna detection, human papillomavirus - cobas 4800 HPV Amplification/Detection Kit, 240 Tests; cobas 4800 HPV Amplification/Detection Kit, 960 Tests; cobas 4800 HPV Controls Kit, 10 Sets; cobas 4800 System cobas HPV AP software; cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests; cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests; cobas 4800 System Sample Preparation Kit, 240 Tests; cobas 4800 System Sample Preparation Kit, 960 Tests; cobas 4800 System Wash Buffer Kit, 240 Tests; cobas 4800 System Wash Buffer Kit, 960 Tests; cobas HPV Test; cobas Sample Prep Buffer; cobas x480 system; cobas z480 Analyzer; cobas z480 system; KIT cobas 4800 HPV AMP/DET 240T US-IVD; KIT cobas 4800 HPV AMP/DET 960T US-IVD; KIT cobas 4800 HPV CONTROLS 10 SETS IVD; KIT cobas 4800 SYS LIQ CYT PREP 240T IVD; KIT cobas 4800 SYS LIQ CYT PREP 960T IVD; KIT cobas 4800 SYS SAMPLE PREP 240T IVD; KIT cobas 4800 SYS SAMPLE PREP 960T IVD; KIT cobas 4800 SYS WASH BUFFER 240T IVD; KIT cobas 4800 SYS WASH BUFFER 960T IVD; KIT COBAS SAMPLE PREP BUFFER 480T IVD; SW C4800 HPV AP v2.1.0 CD; SW COBAS 4800 FSE TOOLS CD 3.0; SW cobas 4800 UDF v2.0.0 CD; SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD

Specification Developer

kit, dna detection, human papillomavirus - KIT COBAS 58/68/8800 HPV 480T IVD; KIT COBAS 58/68/8800 HPV RMC IVD; KIT COBAS 6800/8800 BUFF NEG RMC IVD; KIT COBAS 6800/8800 HPV 480T IVD; KIT COBAS 6800/8800 HPV RMC IVD

Specification Developer

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