TCME MISCELLANEOUS

TCME MISCELLANEOUS
TCME MISCELLANEOUS - MISC M TCME

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

• Total Volume: 50 Milliliter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LAS

Device Name: Drug Specific Control Materials

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: TX

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: 862.3280

Third Party Flag: N

Medical Specialty: TX

Device Id: B800MISCMTCME5

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B800MISCMTCME0

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

Device Id: B800MISCMTCME0

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A