TBIL (Total Bilirubin) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT AU-228 - AU-228
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.
Environmental Conditions
- Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- 30.00
- 8.00
Device Sizes
- Total Volume: 10 Milliliter
- Total Volume: 2.5 Milliliter
- Total Volume: 60 Milliliter
- Kit contains 3 R1, 3 R2, 1 R3 and 1 package insert
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CIG
Device Name: Diazo Colorimetry, Bilirubin
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
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: 862.1110
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302020700
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