17-OH-Progesterone ELISA 30223011

GUDID 04049325033627

17-OH-Progesterone ELISA - 96 Determinations

IBL International GmbH

17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049325033627
NIH Device Record Key032627c5-a64f-4180-85f5-c7d72e9f99d2
Commercial Distribution StatusIn Commercial Distribution
Brand Name17-OH-Progesterone ELISA
Version Model Number30223011
Catalog Number30223011
Company DUNS312694785
Company NameIBL International GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com
Phone+49405328910
EmailIBL@Tecan.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049325033627 [Primary]

FDA Product Code

JLXRadioimmunoassay, 17-Hydroxyprogesterone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-11
Device Publish Date2022-12-28

Devices Manufactured by IBL International GmbH

04049325033627 - 17-OH-Progesterone ELISA2024-04-1117-OH-Progesterone ELISA - 96 Determinations
04049325033627 - 17-OH-Progesterone ELISA2024-04-11 17-OH-Progesterone ELISA - 96 Determinations
04049325030534 - 17beta-Estradiol Saliva Luminescence Immunoassay2023-10-09 17beta-Estradiol Saliva Luminescence Immunoassay - 96 Determinations
04049325030541 - 17beta-Estradiol Saliva Luminescence Immunoassay2023-10-09 17beta-Estradiol Saliva Luminescence Immunoassay - 10 x 96 Determinations
04049325030558 - 17beta-Estradiol Saliva ELISA2023-03-17 17beta-Estradiol Saliva ELISA - 96 Determinations
04049325001787 - DHEA-S ELISA2021-01-06 DHEA-S ELISA - 96 Determinations
04049325003521 - Progesterone Luminescence Immunoassay2021-01-06 Progesterone Luminescence Immunoassay - 96 Determinations
04049325003538 - Progesterone Luminescence Immunoassay2021-01-06 Progesterone Luminescence Immunoassy - 10 x 96 Determinations
04049325003606 - SaliCaps2021-01-06 SaliCaps - 100 Tubes

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