← Back to catalogue

FastPack® IP Vitamin D Kit Complete

FDA UDI

Class II (US FDA UDI)

by Qualigen Inc.

Identity

Trade Name
FastPack® IP Vitamin D Kit Complete FDA UDI
Generic Name
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
30 Test Vit. D Immunoassay Complete Kit w/Cal and Control FDA UDI
Model / Reference
Vit. D Immunoassay FDA UDI
Description
30 Test Vit. D Immunoassay Complete Kit w/Cal and Control FDA UDI

Identifiers

Catalog Number
25000068, 25000073 FDA UDI
Primary DI / UDI-DI
10816467020157 FDA UDI
510(k) Number
K123983 FDA UDI
FDA Product Code
MRG FDA UDI
GMDN Term
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1825 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

FastPack® IP Vitamin D Kit Complete by Qualigen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K123983 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Qualigen Inc.

Sources (1)

  • FDA UDI e39b6f6d-f902-498f-a99d-385b23ee771e 37 fields · synced May 31, 2026