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Seracult Plus Fecal Occult Blood Test Developer

FDA UDI

Class II (US FDA UDI)

by Propper Manufacturing Co., Inc.

Identity

Trade Name
Seracult Plus Fecal Occult Blood Test Developer FDA UDI
Generic Name
Faecal occult blood IVD, reagent FDA UDI
Device Name
Seracult Plus Fecal Occult Blood Test Developer FDA UDI
Model / Reference
37701500 FDA UDI
Description
Seracult Plus Fecal Occult Blood Test Developer FDA UDI

Identifiers

Primary DI / UDI-DI
30818087013100 FDA UDI
510(k) Number
K834297 FDA UDI
FDA Product Code
KHE FDA UDI
GMDN Term
Faecal occult blood IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 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

No

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: Faecal occult blood IVD, reagent

Seracult Plus Fecal Occult Blood Test Developer by Propper Manufacturing Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal occult blood IVD, reagent.

Cleared under the same submission

K834297 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Propper Manufacturing Co., Inc.

Sources (1)

  • FDA UDI 252a1564-b1b8-46c9-b527-650f57e0d675 34 fields · synced Jun 6, 2026