FDA.reportPublic FDA data

VARIANT nbs

Primary DI
00847817008313
Brand
VARIANT nbs
Company
BIO-RAD LABORATORIES, INC.
Model
250-3004
Catalog number
2503004
Device description
VARIANT nbs Sickle Cell Program Retention Time Marker Set
Published
2016-09-12
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
GKAABNORMAL HEMOGLOBIN QUANTITATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKAAbnormal Hemoglobin QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051072000BIO-RAD VARIANT NBS SICKLE CELL PROGRAMBio-Rad Laboratories, Inc.2005-05-12GKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817008313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817008313008478170083138478170083130847817008313

GMDN Terms#

Term, Definition table
TermDefinition
Inherited haemoglobinopathy IVD, controlA material which is used to verify the performance of an assay intended to be 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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
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
03607360012444CAPILLARYS 3 DBSSEBIAGKA2024-04-30
03607360025062CAPI 3 NEONAT HbSEBIAGKA2024-04-30
03607360025635CAPI 3 NEONAT HEMOLYSING SOLUTIONSEBIAGKA2024-04-30
03607360025789CAPILLARYS 3 DBS MICROPLATESSEBIAGKA2024-04-30
00847817000560VARIANT nbs Newborn ScreeningBIO-RAD LABORATORIES, INC.GKA2023-01-31
00847817007057Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007064Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007071Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007156Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007170Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007187Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
03607360020074CAPILLARYS HEMOGLOBINSEBIAGKA2018-01-24
03607360022078MINICAP HEMOGLOBINSEBIAGKA2018-01-24
05391516744102Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516744119Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748179Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748186Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
00847817007354VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008276VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008283VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008306VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008344VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008351VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
M52551250Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551270Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551280Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
05391516744195Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744201Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744232Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744249Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06