25OH Vitamin D Total ELISA 38-25DHU-E01

GUDID B2423825DHUE010

The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human ser

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB2423825DHUE010
NIH Device Record Key779e2f80-6930-444a-bcb1-5957e2158f36
Commercial Distribution StatusIn Commercial Distribution
Brand Name25OH Vitamin D Total ELISA
Version Model Number38-25DHU-E01
Catalog Number38-25DHU-E01
Company DUNS784143778
Company NameAMERICAN LABORATORY PRODUCTS COMPANY, LTD.
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 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

Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB2423825DHUE010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRGSystem, Test, Vitamin D

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-18

Devices Manufactured by AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

B24211GLUHUE010 - Glucagon ELISA2024-10-31 The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma sa
B24280PANHUFC1000 - ALPCO Pancreatic Elastase CLIA2024-08-02 The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for t
B24220TT3HUE011 - Total Triiodothyronine (Total T3) ELISA2024-07-30 The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) co
B24280CALPHUIT2000 - ALPCO Calprotectin Immunoturbidimetric Assay2023-08-28 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu
B24280CALPHUITCAL0 - Calprotectin Immunoturbidimetric Assay - Calibrators2023-08-28 The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidi
B24280CALPHUITCON0 - ALPCO Calprotectin Immunoturbidimetric Assay2023-08-28 The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimet
B24280CALPHUIT100 - ALPCO Calprotectin Immunoturbidimetric Assay2023-06-19 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu
B24220EDLHUUE010 - Ultrasensitive Estradiol ELISA2023-06-15 The Ultrasensitive Estradiol ELISA is an enzyme immunoassay for the quantitative measurement of estradiol in serum or plasma (ED

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