Phoenix Diagnostics PH5009

GUDID 00852676007070

LiquiCV EZ Enzyme Linearity Control

PHOENIX DIAGNOSTICS, INC.

Multiple clinical chemistry enzyme IVD, control

Primary Device ID	00852676007070
NIH Device Record Key	8c8cb615-f467-4a55-91be-f4523af489d8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Phoenix Diagnostics
Version Model Number	PH5009
Catalog Number	PH5009
Company DUNS	606814960
Company Name	PHOENIX DIAGNOSTICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com
Phone	5086558310
Email	sales@phoenixdiagnostics.com

Device Dimensions

Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852676007070 [Primary]
GS1	10852676007077 [Package] Package: Kit [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K912718

FDA Product Code

JJY	Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-08-17
Device Publish Date	2023-08-09

On-Brand Devices [Phoenix Diagnostics]

10853366007018	ISE Buffer Solution for Olympus AU Series Chemistry Systems
00853366007615	Universal Cal Pack (Snap Pack) for Menarini SpotLyte Series Electrolyte Systems
00853366007608	Universal Cal Pack (Snap Pack) for Medica EasyLyte Series Electrolyte Systems
00853366007486	ISE Reagent Pack for Roche / AVL 9180 & 9181 Series Electrolyte Systems
00853366007462	ISE Reagent Pack for Roche / AVL 9120 & 9130 Series Electrolyte Systems
10853366007391	Fast Detergent 2 for Tokyo Boeki BiOLiS Series Chemistry Systems
10853366007384	Fast Detergent 1 for Tokyo Boeki BiOLiS Series Chemistry Systems
00853366007370	Calibrator 2 for Tokyo Boeki BiOLiS Series Chemistry Systems
00853366007363	Calibrator 1 for Tokyo Boeki BiOLiS Series Chemistry Systems
10853366007292	Na / Cl Calibrator for Roche / Hitachi Chemistry Systems
00853366007288	K Calibrator for Roche / Hitachi Chemistry Systems
08533660072244	Hitergent for Roche / Hitachi 900 Series
10853366007223	ISE Standard High for Roche / Hitachi Chemistry Systems
10853366007216	ISE Standard Low for Roche / Hitachi Chemistry Systems
00853366007196	ISE 1N KCL Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems
10853366007179	ISE Internal Ref Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems
10853366007148	ISE Diluent for Roche / Hitachi 704, 902, and P800 Series Chemistry Systems
10853366007056	ISE High Serum Standard for Olympus AU Series Chemistry Systems
10853366007049	ISE Low Serum Standard for Olympus AU Series Chemistry Systems
10853366007025	ISE Mid Standard Solution for Olympus AU Series Chemistry Systems
10852676009774	Cal 1 for NuLyte Systems
10852676007053	Buffer Pack 348 for Siemens / Bayer Blood Gas Systems
01085267600704	Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
10852676007022	Slope Solution 238 for Bayer / Ciba-Corning Blood Gas Systems
00852676009784	Calibrator 2 for Perlong Systems
00852676007216	LiquiCV STAT - Blood Gas / Electrolyte / Metabolite Linearity Control for Abbott iSTAT
00852676007209	LiquiCV BGM - Blood Gas / Electrolyte / Metabolite Linearity Control
00852676007193	LiquiCV BGP - Blood Gas / Electrolyte / Metabolite Linearity Control (Protein)
00852676007186	LiquiTrol ISE - Electrolyte Control - L3
00852676007179	LiquiTrol ISE - Electrolyte Control - L2
00852676007162	LiquiTrol ISE - Electrolyte Control - L1
00852676007155	LiquiTrol ISE - Electrolyte Control - Trilevel
00852676007148	LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - Trilevel
00852676007131	LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L3
00852676007124	LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L2
10852676007114	LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L1
10852676007107	LiquiCV MA - Multi-Analyte Linearity Control
10852676007091	LiquiTrol LP Lipid Control - L2
10852676007084	LiquiTrol LP Lipid Control - L1
00852676007070	LiquiCV EZ Enzyme Linearity Control
10852676007060	Wash Pack 348 for Siemens / Bayer Blood Gas Systems