FDA.reportPublic FDA data

Lyphochek

Primary DI
00847661001843
Brand
Lyphochek
Company
BIO-RAD LABORATORIES, INC.
Model
528X
Catalog number
528X
Device description
Lyphochek Whole Blood Metals Control MiniPak (A human whole blood assayed metals control.)
Published
2017-01-09
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
DIEHEAVY METALS CONTROL MATERIALS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIEHeavy Metals Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020610000LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529Bio-Rad2002-04-22DIE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661001843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661001843008476610018438476610018430847661001843

GMDN Terms#

Term, Definition table
TermDefinition
Multiple heavy metal IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple heavy metals 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
00847661000280LyphochekBIO-RAD LABORATORIES, INC.DIE2017-01-09
00847661000297LyphochekBIO-RAD LABORATORIES, INC.DIE2017-01-09
00847661001683LyphochekBIO-RAD LABORATORIES, INC.DIE2017-01-09
00847661001690LyphochekBIO-RAD LABORATORIES, INC.DIE2017-01-09
00847661001706LyphochekBIO-RAD LABORATORIES, INC.DIE2017-01-09
00847661004073LyphochekBIO-RAD LABORATORIES, INC.DIE2017-01-09