GS 26224

GUDID 00847865013215

GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL

Bio-RAD Laboratories, Inc.

HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator HIV1/HIV2 antigen/antibody IVD, calibrator
Primary Device ID00847865013215
NIH Device Record Keyd7a04e5f-fe3f-4f35-9922-37db881e40e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGS
Version Model Number26224
Catalog Number26224
Company DUNS844766394
Company NameBio-RAD Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com

Device Dimensions

Total Volume1.7 Milliliter
Total Volume1.7 Milliliter
Total Volume1.7 Milliliter
Total Volume1.7 Milliliter
Total Volume1.7 Milliliter
Total Volume1.7 Milliliter
Total Volume1.7 Milliliter
Total Volume1.7 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847865013215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, Hiv Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-23
Device Publish Date2014-08-22

On-Brand Devices [GS]

00847865018845Plate Sealers 25/pkg x 40pkgs
00847865013253GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL
00847865013246GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL
00847865013239GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL
00847865013222GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL
00847865013215GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL
00847865013208GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL
00847865013192GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL
00847865013185GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL
00847865011563Human Immunodeficiency Virus Type 2, GS HIV-2 EIA, 480-Test Kit
00847865010672GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL
00847865010665GS HIV Combo Ag/Ab EIA, 960 Tests
00847865010658GS HIV Combo Ag/Ab EIA, 192 Tests
00847865003063HIV-1 Western Blot, Strip Folder 10/pkg
00847865003056HIV-1 Western Blot, Strip Worksheet 50/pkg
00847865003049Human Immunodeficiency Virus Type 1 GS HIV-1 Western Blot, (40 Tests)
00847865002752HIV-1 Western Blot, Specimen Diluent/Wash (5X), 100 mL
00847865002028HIV-1/HIV-2 PLUS O EIA Specimen Diluent, 100 mL
00847865002011HIV-1/HIV-2 PLUS O EIA Conjugate Concentrate, 12 mL
00847865002004HIV-1/HIV-2 PLUS O EIA Conjugate Diluent, 120 mL
00847865001991HIV-1/HIV-2 PLUS O EIA HIV-1 Group O Positive Control, 1.4 mL
00847865001984HIV-1/HIV-2 PLUS O EIA HIV-2 Positive Control, 1.4 mL
00847865001977HIV-1/HIV-2 PLUS O EIA HIV-1 Positive Control, 1.4 mL
00847865001960HIV-1/HIV-2 PLUS O EIA HIV Negative Control, 8 mL
00847865001953Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 P
00847865001946Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PL
00847865001939Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PL
00847865001922Antibody to Hepatitis B Surface Antigen (Human) GS HBsAg 3.0 - HBsAg Confirmatory Assay 3.0
00847865001892HBsAg EIA 3.0 Low Positive Control, 8 mL
00847865001885HBsAg EIA 3.0 Positive Control, 8 mL
00847865001878HBsAg EIA 3.0 Negative Control, 12 mL
00847865001861HBsAg EIA 3.0 Conjugate Diluent, 120 mL
00847865001854HBsAg EIA 3.0 Conjugate Concentrate, 1.2 mL
00847865001847Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 4800 Tests
00847865001830Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests
00847865001823Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 480 Tests
03610522112777GS HIV Combo Ag/Ab EIA, 192 Tests
03610522112791GS HIV Combo Ag/Ab EIA, 4800 Tests
03610522112784GS HIV Combo Ag/Ab, 960 Tests
03610522110414Conjugate 2 Diluent, GS HIV Combo Ag/Ab, 120mL
03610522110209Conjugate 2, GS HIV Combo Ag/Ab, 12 mL
03610520179871GS HIV Combo Ag/Ab EIA, 4800 Tests
03610520505304Western Blot Trays & Lids 8/pkg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.