FDA.reportPublic FDA data

Atellica CH Billirubin Calibrator (BILI CAL)

Primary DI
00630414615097
Brand
Atellica CH Billirubin Calibrator (BILI CAL)
Company
Siemens Healthcare Diagnostics Inc.
Model
11537243
Catalog number
11537243
Device description
Atellica CH Bilirubin Calibrator (BILI CAL)
Published
2024-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JISCalibrator, primary
JIXCalibrator, multi-analyte mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414615097PrimaryGS10
00630414313450Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414615097006304146150976304146150970630414615097
00630414313450006304143134506304143134500630414313450

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile 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 detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414482446ADVIA® Chemistry LIP Lipase Reagents10311896103118962020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase Reagents10315176103151762020-09-24
00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014136Teco Diagnostics TC Chemistry Calibrator ITECO DIAGNOSTICSJIX2026-08-25
07613336172841CalSet DHEA-S IIRoche Diagnostics GmbHJIS2026-08-07
08430793040839Aptiva® APS IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2026-06-10
00811727018977POINTE Chemistry Calibrator SetHORIBA INSTRUMENTS INCORPORATEDJIX2026-05-01
00850083817008Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817015Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817039Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10758750035373VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
00850033167184Smartest Persona II Multi Blood Glucose Monitoring SystemGlobalmed Holdings, LLCJIX2024-12-02
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
08430793040907Aptiva® APS IgM CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00630414611297Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414636672Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
10758750034635VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
08430793040181Aptiva® CTD Essential CalibratorsINOVA DIAGNOSTICS, INC.JIX2023-12-14
00630414610863Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
00380740131357AlinityAbbott GmbHJIS2020-11-06
00816426021464K-ASSAY® RF Calibrator (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCJIS2020-11-03
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
14987481164557HDL-C/LDL-C CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIS2020-10-23
14987481164564L-Type HDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONJIS2020-10-23
14987481164571L-Type HDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONJIS2020-10-23