FDA.reportPublic FDA data

Lyphochek

Primary DI
00847661002093
Brand
Lyphochek
Company
BIO-RAD LABORATORIES, INC.
Model
553X
Catalog number
553X
Device description
Lyphochek Hemoglobin A2 Control Bilevel MiniPak (A human whole blood assayed Hemoglobin A2 control.)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCMCONTROL, HEMOGLOBIN, ABNORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCMControl, Hemoglobin, AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911347000LYPHOCHEK(R) HEMOGLOBIN A2 CONTROLBio-Rad1991-06-10JCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661002093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661002093008476610020938476610020930847661002093

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin A2 (HbA2) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype A2 (HbA2) in a clinical specimen.

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)854-6737qsd.techservice@bio-rad.com

Regulatory Flags#

DUNS number
051624070
Device count
1
Lot or batch
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
03607360047576CAPI 3 NEONAT Hb AF ControlSEBIAJCM2024-04-30
03607360047927Hb AFSC ControlSEBIAJCM2024-04-30
03607360047583Hb AFSA2 CONTROL (1)SEBIAJCM2023-07-27
03607360047590Hb AFSA2 CONTROL (5)SEBIAJCM2023-07-27
06438147385478RESOLVE Hb FACS Control kitWallac OyJCM2023-04-17
B115ABCARD11371Advin Multi-Drug Screen Test ADVIN BIOTECH, INC.JCM2021-12-17
09421902348051Tosoh USCANTERBURY SCIENTIFIC LIMITEDJCM2018-11-02
09421902348105Tosoh EUCANTERBURY SCIENTIFIC LIMITEDJCM2018-11-02
09421902348020ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
09421902348037ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
09421902348044ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
00847661000884LyphochekBIO-RAD LABORATORIES, INC.JCM2016-09-12
M52553330Abnormal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATIONJCM2016-09-07
M52553390Normal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATIONJCM2016-09-07
05391516744393Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516744409Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748315Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748322Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06