FDA.reportPublic FDA data

Liquichek

Primary DI
00847661001447
Brand
Liquichek
Company
BIO-RAD LABORATORIES, INC.
Model
547
Catalog number
547
Device description
Liquichek Tumor Marker Control Level 1 (A human based assayed tumor marker control.)
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661001447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661001447008476610014478476610014470847661001447

GMDN Terms#

Term, Definition table
TermDefinition
Multiple tissue-associated protein/tumour marker 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 proteins or tumour markers associated with specific tissues in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-70 Degrees Celsius-20 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522231072Liquichek12015644120156442024-05-24
03610522231089Liquichek12015645120156452024-05-24
03610522231096Liquichek12015646120156462024-05-24
03610522231102Liquichek12015647120156472024-05-24
03610522231119Liquichek12015648120156482024-05-24
03610522231461InteliQ12015705120157052024-05-24
03610522231478InteliQ12015706120157062024-05-24
03610522231485InteliQ12015707120157072024-05-24
03610522231492InteliQ12015708120157082024-05-24
03610522231508InteliQ12015709120157092024-05-24
03610522354658Liquichek12019576120195762024-05-24
03610522354665InteliQ12019558120195582024-05-24
00847661004080Quest Diagnostics9559552023-10-09
03610520540916Quest Diagnostics9309302023-10-09
03610520540923Quest Diagnostics9359352023-10-09
03610520540930Quest Diagnostics9459452023-10-09
03610521168942Geenius72480724802023-07-28
03610522162239Geenius12012482120124822023-07-28
03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391523442565 Multichem CSF Plus TECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442572Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442589Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442596Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442602Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442619Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442626Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
03701700819400ELITROL IVITALSCIENTIFICJJY2026-03-04
03701700819509ELITROL IIVITALSCIENTIFICJJY2026-03-04
07333066024035EliA IgM Calibrator WellPhadia ABJJY2026-01-29
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05430003908525LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908532LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908549LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908556LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908563SEEKER®Lacar MDX TechnologiesJJY2026-01-15
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00884883009325MAS Omni•IMMUNE Max, Level 3Microgenics CorporationJJY2025-08-12
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00884883009349MAS Omni•IMMUNE PRO Max, Level 1Microgenics CorporationJJY2025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2Microgenics CorporationJJY2025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3Microgenics CorporationJJY2025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackMicrogenics CorporationJJY2025-08-12
04250317552747Dried Blood ControlChromsystems Instruments + Chemicals GmbHJJY2025-07-31
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