Primary Device ID | 00847817011931 |
NIH Device Record Key | 2d3ae049-3a41-43e2-946f-4497f244828e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VARIANT II Hemoglobin A1c |
Version Model Number | 270-2111NU |
Catalog Number | 2702111NU |
Company DUNS | 132528295 |
Company Name | BIO-RAD LABORATORIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com | |
Phone | +1(800)224-6723 |
diagcs@bio-rad.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847817011931 [Primary] |
LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-01-23 |
Device Publish Date | 2016-09-12 |
00847817014185 | VARIANT II Hemoglobin A1c Program Prefilter |
00847817011979 | VARIANT II Hemoglobin A1c Program Calibrator/Diluent Set |
00847817011955 | VARIANT II Hemoglobin A1c Program Analytical Cartridge |
00847817011948 | VARIANT II Hemoglobin A1c Program Wash/Diluent Solution |
00847817011931 | VARIANT II Hemoglobin A1c Program Elution Buffer B |
00847817011924 | VARIANT II Hemoglobin A1c Program Elution Buffer A |
00847817000324 | VARIANT II Hemoglobin A1c Program Reorder Pack |