Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes B2A102

GUDID 00816068020047

For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, one 25mL bottle of Sulfanilic Acid Solution, one 25mL bottle of 0.2N Hydrochloric Acid, one 50mg Sodium Nitrite Tablet and 100 Cuvettes.

ADVANCED INSTRUMENTS, INC.

Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Primary Device ID00816068020047
NIH Device Record Key7f114b5a-0380-4aea-8e32-508e349cd6c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes
Version Model NumberB2A102
Catalog NumberB2A102
Company DUNS125006353
Company NameADVANCED INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816068020047 [Primary]

FDA Product Code

CIGDiazo Colorimetry, Bilirubin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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