FDA.reportPublic FDA data

25OH Vitamin D Total ELISA

Primary DI
B2423825DHUE010
Brand
25OH Vitamin D Total ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
38-25DHU-E01
Catalog number
38-25DHU-E01
Device description
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 serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.
Published
2017-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRGSystem, Test, Vitamin D

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRGSystem, Test, Vitamin DClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K12336400025OH VITAMIN D TOTAL ELISA TESTDiasource Immunoassays, S.A.2013-07-15MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2423825DHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy Vitamin D in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control Set80-PANHU-FCSET2025-06-06
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00816870023403Vit D Direct AccuBind ELISA Test System - 96 wellsMONOBIND, INC.MRG2024-09-13
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00852169008386ClearChem Diagnostics Inc. Vitamin D (25-OH-D) SetCLEARCHEM DIAGNOSTICS INC.MRG2023-01-20
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