DS360 Column (1,000-Test)

DS360 Column (1,000
Drew - 099-024

A non-reactive suspension medium containing beaded particles, with or without added agglutination enhancing reagents (e.g., LISS, enzymes), presented as a a set of gels or solid phase columns and intended to be used in testing a clinical specimen for red blood cell antigens and/or antibodies, using a column agglutination technique.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LCP

Device Name: Assay, Glycosylated Hemoglobin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

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: 864.7470

Third Party Flag: N

Medical Specialty: HE

Device Id: 00817274020241

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