FDA.reportPublic FDA data

VARIANT II

Primary DI
00847817014949
Brand
VARIANT II
Company
BIO-RAD LABORATORIES, INC.
Model
2702000
Catalog number
2702000
Device description
VARIANT II
Published
2023-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDMINSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDMInstrumentation, High Pressure Liquid ChromatographyClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817014949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817014949008478170149498478170149490847817014949

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags#

DUNS number
132528295
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03610522126750D-10BIO-RAD LABORATORIES, INC.LDM2023-06-12
00847817003516D-10BIO-RAD LABORATORIES, INC.LDM2023-01-31
00847817006098D-10BIO-RAD LABORATORIES, INC.LDM2023-01-31
00847817015786VARIANT II TURBOBIO-RAD LABORATORIES, INC.LDM2023-01-31
03610522060696D-100BIO-RAD LABORATORIES, INC.LDM2023-01-31
00816776020445AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020452AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020469AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020476AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020315AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-06
00816776020087AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020094AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020100AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020117AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020025AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020032AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020049AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020063AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020070AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00847817007163Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.LDM2020-07-01
00847817006791Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.LDM2020-06-24