Vitamin D Control

Vitamin D Control

Fujirebio Diagnostics, Inc. continues its commitment to the development and manufacture of high quality, serum- based multi-constituent controls with the addition of our Vitamin D Control. The Fujirebio Diagnostics Vitamin D Control is an assayed, tri-level control containing both 25(OH) Vitamin D2 and 25(OH) Vitamin D3.

The Fujirebio Diagnostics Vitamin D Control can be utilized as an independent, internal quality control to monitor the precision of the laboratory’s Vitamin D assays. Laboratories can feel confident releasing their patient results when using a control containing both 25(OH) Vitamin D2 and 25 (OH) Vitamin D3 to assess the long-term accuracy and precision of their Vitamin D assays.

Vitamin D Control:

  • Contains both Vitamin D sufficiency indicators: 25(OH) Vitamin D2 and 25(OH) Vitamin D3
  • Three levels of control that span clinically relevant concentrations
  • Value-assigned for multiple platforms
  • Lyophilized, serum-based matrix
  • Reconstituted stability up to 14 days at 2-8°C
  • Reconstituted stability up to 60 days at ≤ -10°C
  • Stable for 9 freeze/thaw cycles
  • Reputation as a "high quality" IVD manufacturer

Intended Use

For In Vitro Diagnostic Use Only

Fujirebio Diagnostics Vitamin D Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.

Description

Name Catalog
Number		 Matrix Levels Quantity
Vitamin D Control1 2130152 Human
Serum
Matrix		 3 Level 1: 2 x 2 mL
Level 2: 2 x 2 mL
Level 3: 2 x 2 mL

(1) in vitro Diagnostic Product

Packaging: 6 x 2 mL (2 vials of each of 3 levels – Lyophilized)

Typical Values

These values are provided solely for the convenience of the laboratory prior to the assessment of the control. Values were obtained from testing performed using the DiaSorin 25-Hydroxyvitamin D 125 I RIA Kit.

Analyte Reference
Ranges2		 Typical
Range
Level 1		 Typical
Range
Level 2		 Typical
Range
Level 3		 Units
25(OH)
Vitamin D		 40 – 100 8.5 – 11.5 25.5 – 34.5 59.5 – 80.5 ng/mL
25(OH)
Vitamin D		 100 – 250 21.2 – 28.7 64.0 – 86.0 149 - 201 nmol/L

(2) DiaSorin Stillwater, MN. 25-Hydroxyvitamin D 125 I RIA Kit Insert, 12654E, 31415 8/07

For more information and to place an order, contact us at customerservice@fdi.com or 1-888-499-9998.

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