FDA.reportPublic FDA data

Estrone-sulfate RIA

Primary DI
15099590211547
Brand
Estrone-sulfate RIA
Company
IMMUNOTECH s.r.o.
Model
DSL5400
Catalog number
DSL5400
Device description
Estrone-sulfate RIA
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CGFRadioimmunoassay, Estrone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGFRadioimmunoassay, EstroneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970915000DSL ESTRONE-SULFATE RIADiagnostic Systems Laboratories, Inc.1997-05-16CGF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590211547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959021154715099590211547

GMDN Terms#

Term, Definition table
TermDefinition
Estrone sulfate (oestrone sulfate) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estrone sulfate (oestrone sulfate) in a clinical specimen, using a radioimmunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
360561849
Device count
1
Kit
true
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
15099590211509DHEA-S-7 RIADSL2700DSL27002023-07-06
15099590211523Ultra-sensitive Estradiol RIADSL4800DSL48002023-07-06
15099590211530ACTIVE Free Testosterone RIADSL4900DSL49002023-07-06
15099590211615Estrone RIADSL8700DSL87002023-07-06
15099590211622DHEA RIADSL8900DSL89002023-07-06
15099590211592ACTIVE Aldosterone RIADSL8600DSL86002016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474040791Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474041743Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474046540Estrone SerumDRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-26
00840239041746Estrone ELISADRG International IncCGF2023-08-25
15099590211615Estrone RIAIMMUNOTECH s.r.o.CGF2023-07-06
B652IB59105Estrone ELISAIBL AmericaCGF2023-06-08
04049016148388Estrone ELISAEUROIMMUN Medizinische Labordiagnostika AGCGF2022-12-08
B261CANE4200DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
B261CANE4208PK0DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
00404847441741Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2021-06-07
00840239040794Estrone ELISADRG International IncCGF2021-06-07
00840239046543Estrone Serum ELISADRG International IncCGF2021-06-07
B24211ESRHUE010Estrone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGF2020-09-25
05400569000674Estrone-RIA-CTDiasource Immunoassays S.A. SACGF2020-09-16
05400569005167Estrone ELISADiasource Immunoassays S.A. SACGF2020-01-09