FDA.report

ContrIL Spectrum Control, Level 2

Primary DI
08426950029151
Brand
ContrIL Spectrum Control, Level 2
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00009833650
Catalog number
00009833650
Device description
ContrIL Spectrum Control, Level 2
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

Product Code Classifications

CodeDeviceSpecialtyClass
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950029151PrimaryGS10
18426950029158Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950029151084269500291518426950029151
1842695002915818426950029158

GMDN Terms

TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store ContrIL Spectrum at 2-8°C (the product is stable for only 120 days if stored at 15- 25°C). Protect from direct sunlight.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18006780710techsupport@werfen.com

Regulatory Flags

DUNS number
557223252
Device count
50
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 DIBrandModelCatalogPublished
08430793242998HEMOSIL RIVAROXABAN CONTROLS0020015500000200155002024-07-22
08430793243001HEMOSIL RIVAROXABAN CALIBRATORS0020015400000200154002024-07-22
00195226001129HemosIL Chromogenic Factor IX002001290000200129002024-07-09
00195226000528ACL TOP 77000000280057000002800572024-05-15
00195226000535ACL TOP 770 LAS00000280037000002800372024-05-15
00195226000542ACL TOP 770s00000280017000002800172024-05-15
00195226000559ACL TOP 57000000280047000002800472024-05-15
00195226000566ACL TOP 37000000280067000002800672024-05-15
00195226000641GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests)000774300102023-10-03
00195226000627GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)000774450102023-10-02
00195226000634GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)000774450102023-10-02
00195226000658GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)000774150102023-10-02
00195226000665GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)000774075102023-10-02
00195226000672GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests)000773600112023-10-02
00195226000689GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)000774450112023-10-02
00195226000696GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)000774450102023-10-02
00195226000702GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 150 Tests)000774450102023-10-02
00195226000719GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 75 Tests)000774450102023-10-02
00195226000726GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests)000773600082023-10-02
00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08718734963042CueSee® HyperbaricEurotrol B.V.JJS2026-01-07
00380740153694AlinityABBOTT LABORATORIESJJS2023-10-14
10852676007114Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007124Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007131Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007148Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007155Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007162Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007179Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007186Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007193Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007209Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007216Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00811403014743Mission Control, Level 1Diamond Diagnostics Inc.JJS2023-06-05
00811403014750Mission Control, Level 2Diamond Diagnostics Inc.JJS2023-06-05
00811403014767Mission Control, Level 3Diamond Diagnostics Inc.JJS2023-06-05
00811403014781Mission Control, Level 1-2-3Diamond Diagnostics Inc.JJS2023-06-05
55700699440179QUALICHECK 5+, LEVEL 1Radiometer Medical ApSJJS2022-12-05
55700699440186QUALICHECK 5+, LEVEL 2Radiometer Medical ApSJJS2022-12-05
55700699440193QUALICHECK 5+, LEVEL 3Radiometer Medical ApSJJS2022-12-05
55700699440209QUALICHECK 5+, LEVEL 4Radiometer Medical ApSJJS2022-12-05
55700699440391HEMATOCRIT S7170 QC LEVEL 1Radiometer Medical ApSJJS2022-12-05
55700699440407HEMATOCRIT S7180 QC LEVEL 2Radiometer Medical ApSJJS2022-12-05
55700699440537QUALICHECK 4+, LEVEL 1Radiometer Medical ApSJJS2022-12-05
55700699440544QUALICHECK 4+, LEVEL 2Radiometer Medical ApSJJS2022-12-05
55700699440551QUALICHECK 4+, LEVEL 3Radiometer Medical ApSJJS2022-12-05
55700699440568QUALICHECK 4+, LEVEL 4Radiometer Medical ApSJJS2022-12-05
55700699440742S7735 AUTOCHECK TM 5+, LEVEL 1Radiometer Medical ApSJJS2022-12-05
55700699440759S7745 AUTOCHECK TM 5+, LEVEL 2Radiometer Medical ApSJJS2022-12-05
55700699440766S7755 AUTOCHECK TM 5+, LEVEL 3Radiometer Medical ApSJJS2022-12-05