DHEA RIA DSL8900

GUDID 15099590211622

DHEA RIA

IMMUNOTECH s.r.o.

Dehydroepiandrosterone (DHEA) IVD, kit, radioimmunoassay
Primary Device ID15099590211622
NIH Device Record Key767f054b-af4b-4f99-9b27-15721e6bbe16
Commercial Distribution StatusIn Commercial Distribution
Brand NameDHEA RIA
Version Model NumberDSL8900
Catalog NumberDSL8900
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
GS115099590211622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity

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

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