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SimulTRAC-S Vitamin B12/Folate 125I RIA Kit

FDA UDI

Class II (US FDA UDI)

by Mp Biomedicals, Llc

Identity

Trade Name
SimulTRAC-S Vitamin B12/Folate 125I RIA Kit FDA UDI
Generic Name
Vitamin B12 IVD, kit, radioimmunoassay FDA UDI
Device Name
For the cuantitative determination of Vitamin B12 and Folate in Serum or Plasma. FDA UDI
Model / Reference
06B254819 FDA UDI
Description
For the cuantitative determination of Vitamin B12 and Folate in Serum or Plasma. FDA UDI

Identifiers

Catalog Number
06B254819 FDA UDI
Primary DI / UDI-DI
00817830022603 FDA UDI
510(k) Number
K822728 FDA UDI
FDA Product Code
CGN FDA UDI
GMDN Term
Vitamin B12 IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1295 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

Dimensions & Sizes

Size
Length — 22.86 Centimeter FDA UDI

Category: Vitamin B12 IVD, kit, radioimmunoassay

SimulTRAC-S Vitamin B12/Folate 125I RIA Kit by Mp Biomedicals, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitamin B12 IVD, kit, radioimmunoassay.

Cleared under the same submission

K822728 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mp Biomedicals, Llc

Sources (1)

  • FDA UDI 5b8f1b0f-bbea-4c3a-8918-17681f3c853c 38 fields · synced Jun 8, 2026