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Accutest iFOB Positive and Negative Hemoglobin Controls
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Accutest iFOB Positive and Negative Hemoglobin Controls FDA UDI
- Generic Name
- Biological fluid occult blood screening IVD, control FDA UDI
- Device Name
- Accutest iFOB Positive and Negative Hemoglobin Controls Contains: 1 positive hemoglobin control and 1 negative hemoglobin control FDA UDI
- Model / Reference
- CSC67 FDA UDI
- Description
- Accutest iFOB Positive and Negative Hemoglobin Controls Contains: 1 positive hemoglobin control and 1 negative hemoglobin control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924607058 FDA UDI
- 510(k) Number
- K063693 FDA UDI
- FDA Product Code
- KHE FDA UDI
- GMDN Term
- Biological fluid occult blood screening 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
No
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: Biological fluid occult blood screening IVD, control
Accutest iFOB Positive and Negative Hemoglobin Controls by Jant Pharmacal Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K063693 also covers:
- Accutest iFOBT - Dual Sample Fecal Occult Blood Test — JANT PHARMACAL CORP.
- Accutest iFOBT - Dual Sample Specimen Collection Kits — JANT PHARMACAL CORP.
- Accutest iFOBT - Single Sample Immunological Fecal Occult Blood Test — JANT PHARMACAL CORP.
- Accutest iFOBT - Specimen Collection Kit — JANT PHARMACAL CORP.
- Accutest iFOBT - Specimen Collection Tubes — JANT PHARMACAL CORP.
- ForSure iFOB Test (buffer only) — SYNTRON BIORESEARCH, INC.
- ForSure iFOB Test (cassette only) — SYNTRON BIORESEARCH, INC.
- ForSure iFOB Test Set — SYNTRON BIORESEARCH, INC.
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI b49ecb6e-d9fb-4c29-a7d4-e1f412aee31c 34 fields · synced Jun 8, 2026