Abbott Universal Collection Kit

Abbott Universal Collection Kit
RealTime - 09N77-055

A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QJR

Device Name: Reagents, 2019-Novel Coronavirus Nucleic Acid

Device Class: N

Physical State: In Vitro Diagnostic Primers, Probes and/or capture oligos.

Definition: Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.

Submission Type ID: 8

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Nucleic acid amplification and/or detection.

Life Sustain Support Flag: N

Unclassified Reason: 11

Implant Flag: N

Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 30884999049131

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884999049134

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20884999049134

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00884999049130

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 00884999049130

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