FDA.reportPublic FDA data

Phoenix Diagnostics

Primary DI
00852676007780
Brand
Phoenix Diagnostics
Company
PHOENIX DIAGNOSTICS, INC.
Model
3-602
Device description
Calibrator 2 for Perlong Systems
Published
2020-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852676007787PackageGS14In Commercial Distribution
00852676007780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085267600778710852676007787
00852676007780008526760077808526760077800852676007780

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume200Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
5086558310sales@phoenixdiagnostics.com

Regulatory Flags#

DUNS number
606814960
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852676007121Phoenix Diagnostics1007AM1007AM2023-08-09
10852676007138Phoenix Diagnostics1008AM1008AM2023-08-09
10852676007145Phoenix Diagnostics1009AM1009AM2023-08-09
10852676007152Phoenix Diagnostics1001P1001P2023-08-09
10852676007169Phoenix Diagnostics1002P1002P2023-08-09
10852676007176Phoenix Diagnostics1003P1003P2023-08-09
10852676007183Phoenix Diagnostics1004P1004P2023-08-09
10852676007190Phoenix DiagnosticsPH5001PH50012023-08-09
10852676007206Phoenix DiagnosticsPD500APD500A2023-08-09
10852676007213Phoenix DiagnosticsPD500SPD500S2023-08-09
00852676007063Phoenix Diagnostics3-2243-2242023-08-09
00852676007087Phoenix DiagnosticsPH5041PH50412023-08-09
00852676007094Phoenix DiagnosticsPH5042PH50422023-08-09
00852676007100Phoenix DiagnosticsPH5020PH50202023-08-09
10852676007060Phoenix Diagnostics3-2243-2242023-08-09
00852676007070Phoenix DiagnosticsPH5009PH50092023-08-09
10852676007084Phoenix DiagnosticsPH5041PH50412023-08-09
10852676007091Phoenix DiagnosticsPH5042PH50422023-08-09
10852676007107Phoenix DiagnosticsPH5020PH50202023-08-09
10852676007114Phoenix Diagnostics1006AM1006AM2023-08-09

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Primary DI, Brand, Company table
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00811727018977POINTE Chemistry Calibrator SetHORIBA INSTRUMENTS INCORPORATEDJIX2026-05-01
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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
00850033167184Smartest Persona II Multi Blood Glucose Monitoring SystemGlobalmed Holdings, LLCJIX2024-12-02
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIX2024-04-03
00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2020-05-08
00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
04250317522450Plasma Calibrator Set Chromsystems Instruments + Chemicals GmbHJIX2019-07-26
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04250317542854Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543226Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543233Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543370Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543387Serum Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543394Serum Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22