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FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under S10(k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

The subject device provides HEL, HFF, LLC-MK2, MV1Lu, NCI/H292/ Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1 under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV; Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV; Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups; HSV, CMV; Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps; Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella; Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV. FreshCella™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens.

The subject device provides HEL, HFF, LLC-MK2, MV1Lu/ NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: | CELL LINE/ORIGIN | SPECIFIC VIRUSES | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV,<br>Poliovirus, Rhinovirus, Vesicular stomatitis<br>(Indiana Strain) virus and VZV. | | HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps,<br>Poliovirus, Rhinovirus, VZV. | | LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus,<br>Myxovirus and Poxvirus groups. | | MvlLu/Mink Lung | HSV, CMV. | | NCI-H292/Human, Pulmonary muco-<br>epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK<br>polyomavirus, Reoviruses, Measles virus,<br>RSV, some strains of Influenza type A, most<br>Enteroviruses and Rhinoviruses, Parainfluenza<br>and Mumps. | | Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles,<br>Mumps, Poliovirus type 3, Rotavirus, Rubella | | WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV,<br>Influenza, Mumps, Poliovirus, Rhinovirus,<br>RSV, VZV. | FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

The subject device provides HEL, HFF, LLC-MK2, MVILu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

The subject device provides HEL, HFF, LLC-MK2, MV1Lu, NCI H292, Vero and WI-38 cell lines as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

FreshCells™ are indicated for use in the isolation of Viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

The subject device provides HEL HFF, JAC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, MCCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

RHMK II is intended for use in the isolation and identification of virus from clinical specimens from patients having a viral infection.

RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)

Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV; Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV; Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups; HSV, CMV; Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps; Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella; Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV. FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens.

The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, Rotavirus.

The subject device provides A549 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.