KIP1131

GUDID 05400569000414

Urinary hGH IRMA

Diasource Immunoassays S.A. SA

Human growth hormone (HGH) IVD, kit, radioimmunoassay
Primary Device ID05400569000414
NIH Device Record Key5c58c314-a1c0-4490-b9c3-2302b841b63a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIP1131
Version Model NumberKIP1131
Company DUNS458777323
Company NameDiasource Immunoassays S.A. SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105400569000414 [Primary]

FDA Product Code

CFLRADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-21
Device Publish Date2020-09-11

Devices Manufactured by Diasource Immunoassays S.A. SA

05400569000674 - Estrone-RIA-CT2020-09-24 Estrone-RIA-CT
05400569000360 - E2 RIA CT2020-09-23 E2 RIA CT
05400569000650 - 11-DESOXYCORTISOL-RIA-CT2020-09-23 11-DESOXYCORTISOL-RIA-CT
05400569000049 - C-PEP-EASIA2020-09-22 C-PEP-EASIA
05400569000377 - FSH IRMA2020-09-22 FSH IRMA
05400569000865 - Androstenedione-ELISA2020-09-22 Androstenedione-ELISA
05400569000209 - IGF-1 ELISA2020-09-21 IGF-1 ELISA
05400569000414 - KIP11312020-09-21Urinary hGH IRMA
05400569000414 - KIP11312020-09-21 Urinary hGH IRMA

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