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MAGLUMI 2000 25-OH Vitamin D

FDA UDI

Class II (US FDA UDI)

by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Identity

Trade Name
MAGLUMI 2000 25-OH Vitamin D FDA UDI
Generic Name
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
130211007M FDA UDI

Identifiers

Catalog Number
130211007M FDA UDI
Primary DI / UDI-DI
06947145578053 FDA UDI
510(k) Number
K191499 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

No

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

MAGLUMI 2000 25-OH Vitamin D by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

Cleared under the same submission

K191499 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.

Sources (1)

  • FDA UDI 485b9a91-3480-4205-be43-f67a4a0fa3ed 35 fields · synced Jun 1, 2026