DHEA-S-7 RIA DSL2700

GUDID 15099590211509

DHEA-S-7 RIA

IMMUNOTECH s.r.o.

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, radioimmunoassay
Primary Device ID15099590211509
NIH Device Record Key59bc44d7-96c3-4eed-b122-850112ca6df0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDHEA-S-7 RIA
Version Model NumberDSL2700
Catalog NumberDSL2700
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
GS115099590211509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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.

15099590211509 - DHEA-S-7 RIA2023-07-14DHEA-S-7 RIA
15099590211509 - DHEA-S-7 RIA2023-07-14 DHEA-S-7 RIA
15099590211523 - Ultra-sensitive Estradiol RIA2023-07-14 Ultra-sensitive Estradiol RIA
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 RIA2023-07-14 DHEA RIA

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