Identity
- Trade Name
- HEMOSURE® FDA UDI
- Generic Name
- Faecal occult blood IVD, control FDA UDI
- Device Name
- Hemosure iFOB Controls Set 2ml FDA UDI
- Model / Reference
- T1-TC02 FDA UDI
- Description
- Hemosure iFOB Controls Set 2ml FDA UDI
Identifiers
- Catalog Number
- T1-TC02 FDA UDI
- Primary DI / UDI-DI
- 00857338006163 FDA UDI
- GMDN Term
- Faecal occult blood IVD, control FDA UDI
Classification
- 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, control
Hemosure® by Hemosure Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal occult blood IVD, control.
- FOBT-CHEK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
- InSure FIT — ENTERIX INC. · Class II
- FOBT-CHEK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
- FOBT-CHEK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
- FOBT-CHEK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
- QuickVue — Quidel Corp. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- FOBT-CHEK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemosure Inc.
Sources (1)
- FDA UDI e4e9595d-4724-4dcd-b5b2-f8a7518cdfb3 35 fields · synced May 30, 2026