FDA.reportPublic FDA data

IRON-SL Assay

Primary DI
00628063400645
Brand
IRON-SL Assay
Company
SEKISUI DIAGNOSTICS, LLC
Model
157-30
Catalog number
157-30
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
JIYPhotometric method, iron (non-heme)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIYPhotometric Method, Iron (Non-Heme)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973933000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973933000SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30Diagnostic Chemicals , Ltd.1997-11-04JIY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400645006280634006456280634006450628063400645

GMDN Terms#

Term, Definition table
TermDefinition
Iron IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of iron 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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00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
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Primary DI, Brand, Company table
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