FDA.reportPublic FDA data

Hemoglobin Variants System

Primary DI
00847817006791
Brand
Hemoglobin Variants System
Company
BIO-RAD LABORATORIES, INC.
Model
250-0014
Catalog number
2500014
Device description
Hemoglobin Variants System Cation Exchange Mini-Columns
Published
2020-06-24
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171664000Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.2017-09-13GKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817006791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817006791008478170067918478170067910847817006791

GMDN Terms#

Term, Definition table
TermDefinition
Inherited haemoglobinopathy IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
132528295
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00847817014949VARIANT IIBIO-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