FDA.reportPublic FDA data

PHOENIX DIAGNOSTICS, INC.

Primary DI
10853366007209
Brand
PHOENIX DIAGNOSTICS, INC.
Company
PHOENIX DIAGNOSTICS, INC.
Model
16-227
Device description
ISE 1N KCL Sol for Roche / Hitachi 911 Series Chemistry Systems
Published
2018-01-26
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

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013451000PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESPhoenix Diagnostics, Inc.2001-12-18CGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853366007209PackageGS15In Commercial Distribution
00853366007202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085336600720910853366007209
00853366007202008533660072028533660072020853366007202

GMDN Terms#

Term, Definition table
TermDefinition
Ion selective electrode (ISE) reference solution IVD, reagentA substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606814960
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012589Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014163Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016730Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017133Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08