Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens.

Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens.
PREMIER Rotaclone - 696004

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Rotavirus in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LIQ

Device Name: Enzyme Linked Immunoabsorbent Assay, Rotavirus

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3405

Third Party Flag: N

Medical Specialty: MI

Device Id: 00840733101700

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A