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InSure FIT

FDA UDI

Class II (US FDA UDI)

by Enterix Inc.

Identity

Trade Name
InSure FIT FDA UDI
Generic Name
Faecal occult blood IVD, control FDA UDI
Device Name
InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each) FDA UDI
Model / Reference
01 FDA UDI
Description
InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each) FDA UDI

Identifiers

Catalog Number
16800 FDA UDI
Primary DI / UDI-DI
00850093003033 FDA UDI
510(k) Number
K101831 FDA UDI
FDA Product Code
OSL FDA UDI
GMDN Term
Faecal occult blood IVD, control 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, control

InSure FIT by Enterix Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal occult blood IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Enterix Inc.

Sources (1)

  • FDA UDI 88d8e3d0-cc77-4a03-b1aa-65109693e7bf 36 fields · synced Jun 7, 2026