FDA.reportPublic FDA data

Phoenix Diagnostics

Primary DI
00853366007288
Brand
Phoenix Diagnostics
Company
PHOENIX DIAGNOSTICS, INC.
Model
16-218
Catalog number
16-218
Device description
K Calibrator for Roche / Hitachi Chemistry Systems
Published
2017-04-26
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

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
10853366007285PackageGS110In Commercial Distribution
00853366007288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085336600728510853366007285
00853366007288008533660072888533660072880853366007288

GMDN Terms#

Term, Definition table
TermDefinition
Potassium (K+) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of potassium (K+) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume30Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5086558310sales@phoenixdiagnostics.com

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

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