FDA.reportPublic FDA data

CALCIUM Assay

Primary DI
00628063400256
Brand
CALCIUM Assay
Company
SEKISUI DIAGNOSTICS, LLC
Model
140-20
Catalog number
140-20
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K895873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895873000CALCIUM, CATALOGUE NUMBER140-20Diagnostic Chemicals, Ltd. (Usa)1989-12-12CJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400256006280634002566280634002560628063400256

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00628063400065ALBUMIN Assay200-45200-452016-09-16
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00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
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Primary DI, Brand, Company table
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