Identity
- Trade Name
- AFSC Hemo Control FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, control FDA UDI
- Model / Reference
- 5331 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52553310 FDA UDI
- 510(k) Number
- K800855 FDA UDI
- FDA Product Code
- JBD FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7440 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
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: Inherited haemoglobinopathy IVD, control
AFSC Hemo Control by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inherited haemoglobinopathy IVD, control.
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- Hemoglobin AD Control — Analytical Control Systems · Class II
- Hemoglobin Variants System — Bio-Rad Laboratories · Class II
- Hemoglobin AF Control — Analytical Control Systems · 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI d4ad82e9-f7c2-4789-8554-ab80f36bcc10 34 fields · synced Jun 9, 2026