C-PEP II-RIA-CT

GUDID 05400569000322

C-PEP II-RIA-CT

Diasource Immunoassays S.A. SA

C-peptide IVD, kit, radioimmunoassay
Primary Device ID05400569000322
NIH Device Record Key65aa49d8-dc25-413b-aea7-b24f4a9053ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-PEP II-RIA-CT
Version Model NumberKIP0409
Company DUNS458777323
Company NameDiasource Immunoassays S.A. SA
Device Count1
DM Exempttrue
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
GS105400569000322 [Primary]

FDA Product Code

JKDRADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

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 - KIP11312020-09-21 Urinary hGH IRMA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.