QUANTA LITE®Calprotectin Extended Range

Primary DI
08426950913337
Brand
QUANTA LITE®Calprotectin Extended Range
Company
INOVA DIAGNOSTICS, INC.
Model
704860
Device description
1. Antibody coated plate12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant.2. Enzyme conjugate antibody (IgG)1 vial containing 15 ml Horse-radish peroxidase-labeled rabbit anti-human calprotectin IgG antibodies in a buffer solution with Proclin 300 as a preservative. Ready-to-use.3. Substrate1 vial containing 15 ml substrate reagent (TMB). Ready-to-use4. Stop Solution1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use5. Washing solution (20x)1 vial containing 50 ml concentrated washing solution. To be diluted with distilled water.6. Diluent solution (10x)1 vial containing 20 ml concentrated diluent solution to be diluted with distilled water.7. Extraction solution (2.5x)2 vials containing 100 ml concentrated extraction solution to be diluted with distilled water. This concentrated solution is irritating to eyes and skin.8. Calibrators6 vials containing 1.5 ml Calprotectin solution at six known concentrations (0, 2.5, 12.5, 25, 50, 150 ng/ml). The value of each Calibrator is printed on the vial label. Ready-to-use.9. Control 11 vial containing 1.5 ml of control 1. Ready-to-use. Do not dilute. The range of values is printed on the vial label.10. Control 21 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXOCalprotectin, Fecal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXOCalprotectin, FecalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191592000CalprestNG, EasyCalEurospital S.P.A.2019-07-10NXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950913337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950913337084269509133378426950913337

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with gastrointestinal disease in a clinical specimen, using an enzyme immunoassay (EIA) method. Markers to be assayed may include pepsinogen I, pepsinogen II, gastrin and/or antibodies to the bacteria Helicobacter pylori.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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