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Total Protein

FDA UDI

Class II (US FDA UDI)

by Sekisui Diagnostics, LLC

Identity

Trade Name
TOTAL PROTEIN FDA UDI
Generic Name
Total protein IVD, kit, spectrophotometry FDA UDI
Model / Reference
SK201-10 FDA UDI

Identifiers

Catalog Number
SK201-10 FDA UDI
Primary DI / UDI-DI
00628063400881 FDA UDI
510(k) Number
K843028 FDA UDI
FDA Product Code
CEK FDA UDI
GMDN Term
Total protein IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1635 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Total Protein by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K843028 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sekisui Diagnostics, LLC

Sources (1)

  • FDA UDI 91fb3e83-c416-4b02-88b0-c2b9038c9938 35 fields · synced Jun 9, 2026