ACTIVE Free Testosterone RIA DSL4900

GUDID 15099590211530

ACTIVE Free Testosterone RIA

IMMUNOTECH s.r.o.

Free testosterone IVD, kit, radioimmunoassay
Primary Device ID15099590211530
NIH Device Record Key30af94a8-7ca1-453e-93f0-287e89df1546
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTIVE Free Testosterone RIA
Version Model NumberDSL4900
Catalog NumberDSL4900
Company DUNS360561849
Company NameIMMUNOTECH s.r.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590211530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

Devices Manufactured by IMMUNOTECH s.r.o.

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15099590211530 - ACTIVE Free Testosterone RIA2023-07-14ACTIVE Free Testosterone RIA
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15099590211547 - Estrone-sulfate RIA2023-07-14 Estrone-sulfate RIA
15099590211615 - Estrone RIA2023-07-14 Estrone RIA
15099590211622 - DHEA RIA2023-07-14 DHEA RIA

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