EMD Millipore Corporation

Address:400 Summit Drive,Burlington,MA,01803,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antigen, Cf (Including Cf Control), Cytomegalovirus (GQH) (3) Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 (GQN) (3) Antisera, Fluorescent, Herpesvirus Hominis 1,2 (GQL) (2) Antisera, Conjugated Fluorescent, Cytomegalovirus (LIN) (1) Antisera, Fluorescent, Human Metapneumovirus (OMG) (1)

Premarket Exempt

No Yes

Clear

Light Diagnostics CMV DFA Reagent - 04053252507397 Catalog Number : 5090-2ML

Device Description : Light Diagnostics CMV DFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : LIN

Prescription Use : No

Device Count : 1

Light Diagnostics SimulFluor HSV 1/2 - 04053252515101 Catalog Number : 5243-2mL

Device Description : Light Diagnostics SimulFluor HSV 1/2

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQN

Prescription Use : No

Device Count : 1

Light Diagnostics Human Metapneumovirus (hMPV) Control Slides (5 pack) - 04053252518584 Catalog Number : 5092-5

Device Description : Human Metapneumovirus Control Slides

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : OMG

Prescription Use : No

Device Count : 1

Light Diagnostics CMV Control Slides (5 pack) - 04053252589768 Catalog Number : 5027-5

Device Description : Light Diagnostics CMV Control Slides (5 pack)

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQH

Prescription Use : No

Device Count : 1

Light Diagnostics™ Simulfluor® HSV 1/ HSV 2 DFA Kit - 04053252589942 Catalog Number : 3293

Device Description : Simulfluor HSV 1/ HSV 2 DFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQN

Prescription Use : No

Device Count : 1

Light Diagnostics™ HSV 1&2 Typing DFA Kit - 04053252620638 Catalog Number : 3291

Device Description : HSV 1 & 2 Typing DFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent - 04053252625213 Catalog Number : 5243

Device Description : Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQN

Prescription Use : No

Device Count : 1

Light Diagnostics HSV 2 Typing Reagent - 04053252670930 Catalog Number : 5234

Device Description : Light Diagnostics HSV 2 Typing Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Light Diagnostics CMV IFA Reagent - 04053252671074 Catalog Number : 5026

Device Description : Light Diagnostics CMV IFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQH

Prescription Use : No

Device Count : 1

Light Diagnostics™ CMV IFA Kit - 04053252676024 Catalog Number : 3135

Device Description : CMV IFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQH

Prescription Use : No

Device Count : 1

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