FDA.report

Calibrator Diluent

Primary DI
00847817003363
Brand
Calibrator Diluent
Company
BIO-RAD LABORATORIES, INC.
Model
220-0119
Catalog number
2200119
Device description
Calibrator Diluent
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JITCALIBRATOR, SECONDARY

Product Code Classifications

CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847817003363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817003363008478170033638478170033630847817003363

GMDN Terms

TermDefinition
Glycated haemoglobin (HbA1c) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags

DUNS number
132528295
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
true
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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336222331ISE Internal Standard Gen.2 conc.Roche Diagnostics GmbHJIT2026-03-20
04015630926091Testosterone II CalSet IIRoche Diagnostics GmbHJIT2026-02-23
04560189213418ST AIA-PACK PROG II CALIBRATOR SETTOSOH CORPORATIONJIT2026-02-02
00817089023222DiazymeDIAZYME LABORATORIES, INC.JIT2026-01-21
04562185403060HbA1c Calibrator Set (S)TOSOH CORPORATIONJIT2026-01-05
00380740189822AlinityAbbott GmbHJIT2026-01-01
00380740189846ARCHITECTAbbott GmbHJIT2026-01-01
00380740168742AlinityAbbott Ireland DiagnosticsJIT2025-12-11
07613336216958CalSet Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHJIT2025-11-18
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399671CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399725CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185400407CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
05711435000163ProNephro AKI™ (NGAL) Calibrator KitBioporto Diagnostics A/SJIT2025-08-28
00630414320304Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
07613336180822CalSet Cortisol III UrineRoche Diagnostics GmbHJIT2025-07-24
15099590763633Access Syphilis CalibratorsBeckman Coulter, Inc.JIT2025-05-07
04987595300011PATHFAST Sample Diluent 1PHC CORPORATIONJIT2025-04-18
04987595300028PATHFAST Sample Diluent 2PHC CORPORATIONJIT2025-04-18
04015630924288sFlT-1 CalSetRoche Diagnostics GmbHJIT2025-04-07
04015630925407CalSet PlGFRoche Diagnostics GmbHJIT2025-04-07
05055845400534Alere NT-proBNP for Alinity Calibrator KitAXIS-SHIELD DIAGNOSTICS LIMITEDJIT2025-02-27
08058056685285ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
08058056685315ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
20758750034625VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
20758750035066VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
08430793243001HEMOSIL RIVAROXABAN CALIBRATORSINSTRUMENTATION LABORATORY COMPANYJIT2024-07-22
20758750034915VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25