FDA.reportPublic FDA data

URIC ACID-SL Assay

Primary DI
00628063400997
Brand
URIC ACID-SL Assay
Company
SEKISUI DIAGNOSTICS, LLC
Model
237-60
Catalog number
237-60
Published
2016-09-20
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
KNKAcid, uric, uricase (colorimetric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961586000URIC ACID-SL ASSAY CATALOGUE NO. 237-60Diagnostic Chemicals , Ltd.1996-07-23KNK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400997PrimaryGS10
10628063400994Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400997006280634009976280634009970628063400997
1062806340099410628063400994

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of uric acid in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

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00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
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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
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486002317Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002324Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002331Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSKNK2023-11-15
10673486002348Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002355Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSKNK2023-11-15
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