FDA.reportPublic FDA data

Ca Reagent Kit

Primary DI
00386100002060
Brand
Ca Reagent Kit
Company
MEDICA CORPORATION
Model
10210-4
Catalog number
10210-4
Device description
Calcium Reagent Kit for use with EasyRA Analyzers
Published
2019-02-14
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
CJYAzo Dye, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJYAzo Dye, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072249000EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENTMedica Corp.2008-02-20CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100002060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100002060003861000020603861000020600386100002060

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.

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
781-275-4892technicalsupport@medicacorp.com

Regulatory Flags#

DUNS number
112942404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386100002145ALB Reagent Kit10218-410218-42019-02-14
00386100002008CHOL Reagent Kit 10204-410204-42019-02-14
00386100002022SGOT (AST) Reagent Kit10206-410206-42019-02-14
00386100002039TBIL Reagent Kit10207-410207-42019-02-14
00386100002053CO2 Reagent Kit 10209-410209-42019-02-14
00386100002077HDL CHOL Reagent Kit10211-410211-42019-02-14
00386100002084DBIL Reagent Kit 10212-410212-42019-02-14
00386100002107ALP Reagent Kit 10214-410214-42019-02-14
00386100002121TRIG Reagent Kit10216-410216-42019-02-14
00386100002138AMY Reagent Kit10217-410217-42019-02-14
00386100002169Mg Reagent Kit10220-410220-42019-02-14
00386100002176Phos Reagent Kit10221-410221-42019-02-14
00386100002183CK Reagent Kit 10222-410222-42019-02-14
00386100002190Iron (Fe) Reagent Kit10223-410223-42019-02-14
00386100002206LDL CHOL Reagent Kit 10224-410224-42019-02-14
00386100002213UALB Reagent Kit10225-410225-42019-02-14
00386100002237Lipase Reagent Kit 10227-410227-42019-02-20
00386100002244CRP Reagent Kit10228-410228-42019-02-14
00386100002268HbA1c Reagent Kit 10230-210230-22019-02-14
00386100002046Uric Reagent Kit 10208-410208-42019-02-14

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Primary DI, Brand, Company table
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10758750031795VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJY2019-11-13
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00380740135409AlinityAbbott GmbHCJY2018-08-31
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00817274022450JAS DiagnosticsDREW SCIENTIFIC, INC.CJY2017-04-04
05060500091835Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2017-02-28
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