FDA.reportPublic FDA data

PHOENIX DIAGNOSTICS, INC.

Primary DI
00853366007158
Brand
PHOENIX DIAGNOSTICS, INC.
Company
PHOENIX DIAGNOSTICS, INC.
Model
16-201
Device description
ISE Diluent for Roche / Hitachi 700 & 900 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

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
10853366007155PackageGS16In Commercial Distribution
00853366007158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085336600715510853366007155
00853366007158008533660071588533660071580853366007158

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606814960
Device count
1
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

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