Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Clinitek Novus® Cal 1-4 kit - 10697753
Device Description
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
- Keep Dry, Keep refrigerated and do not freeze
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JMT
Device Name: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1510
Third Party Flag: N
Medical Specialty: CH
Code: KQO
Device Name: Automated Urinalysis System
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.2900
Third Party Flag: N
Medical Specialty: CH
Code: JIX
Device Name: Calibrator, Multi-Analyte Mixture
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1150
Third Party Flag: N
Medical Specialty: CH
Code: JJB
Device Name: Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1115
Third Party Flag: N
Medical Specialty: CH
Code: CDM
Device Name: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1785
Third Party Flag: N
Medical Specialty: CH
Code: JIO
Device Name: Blood, Occult, Colorimetric, In Urine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.6550
Third Party Flag: Y
Medical Specialty: HE
Code: JIL
Device Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1340
Third Party Flag: Y
Medical Specialty: CH
Code: JIN
Device Name: Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1435
Third Party Flag: N
Medical Specialty: CH
Code: JIR
Device Name: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1645
Third Party Flag: N
Medical Specialty: CH
Code: LJX
Device Name: Test, Urine Leukocyte
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.7675
Third Party Flag: N
Medical Specialty: HE
Code: CEN
Device Name: Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1550
Third Party Flag: N
Medical Specialty: CH
Code: JRE
Device Name: Refractometer For Clinical Use
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.2800
Third Party Flag: N
Medical Specialty: CH
Device Identifiers
Device Id: 00630414590950
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
