FDA.reportPublic FDA data

Cholinesterase Liquid

Primary DI
08058056680709
Brand
Cholinesterase Liquid
Company
SENTINEL CH. SPA
Model
17019H
Catalog number
17019H
Device description
The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.
Published
2017-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLIAcetylcholine Chloride, Specific Reagent For Pseudo CholinesteraseClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981800000SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606Equal Diagnostics, Inc.1998-07-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056680709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056680709080580566807098058056680709

GMDN Terms#

Term, Definition table
TermDefinition
Pseudocholinesterase IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the enzyme pseudocholinesterase in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume120Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
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08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
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08058056680228Lp(a) Cal Set11522D11522D2024-03-15
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842768014178Dimension® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DLI2020-09-24
00380740155933ARCHITECTAbbott GmbHDLI2020-03-03