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Instant-view plus Immunochemical Fecal Occult Blood Test

FDA UDI

Class II (US FDA UDI)

by Alfa Scientific Designs, Inc.

Identity

Trade Name
Instant-view plus Immunochemical Fecal Occult Blood Test FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Instant-view plus Immunochemical Fecal Occult Blood Test Fecal Occult Blood – Cassette FDA UDI
Model / Reference
05-7632 FDA UDI
Description
Instant-view plus Immunochemical Fecal Occult Blood Test Fecal Occult Blood – Cassette FDA UDI

Identifiers

Primary DI / UDI-DI
10796918001914 FDA UDI
FDA Product Code
KHE FDA UDI
GMDN Term
Faecal occult blood IVD, kit, rapid ICT, clinical 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

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

Category: Faecal occult blood IVD, kit, rapid ICT, clinical

Instant-view plus Immunochemical Fecal Occult Blood Test by Alfa Scientific Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Faecal occult blood IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alfa Scientific Designs, Inc.

Sources (1)

  • FDA UDI 11db6d69-5743-4998-b3f6-a85fa0bd4e57 33 fields · synced Jun 9, 2026