Identity
- Trade Name
- Hemoglobin AF Control FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, control FDA UDI
- Model / Reference
- HC-103 FDA UDI
Identifiers
- Catalog Number
- HC-103 FDA UDI
- Primary DI / UDI-DI
- 00817869020076 FDA UDI
- 510(k) Number
- K802569 FDA UDI
- FDA Product Code
- KHG FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7500 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
Yes
FDA UDI
Category: Inherited haemoglobinopathy IVD, control
Hemoglobin AF Control by Analytical Control Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inherited haemoglobinopathy IVD, control.
- ASA2 Hemo Control — Helena Laboratories, Corp. · Class II
- AA2 Hemo Control — Helena Laboratories, Corp. · Class II
- AFSC Hemo Control — Helena Laboratories, Corp. · Class II
- Hemoglobin Variants System — Bio-Rad Laboratories · Class II
- VARIANT nbs — Bio-Rad Laboratories · Class II
- AFSA2 Hemo Control — Helena Laboratories, Corp. · Class II
- Hemoglobin Variants System — Bio-Rad Laboratories · Class II
- Hemoglobin A2 Elevated Control — Analytical Control Systems · Class II
Cleared under the same submission
K802569 also covers:
- Hemoglobin A2 Elevated Control — Analytical Control Systems
- Hemoglobin A2 Normal Control — Analytical Control Systems
- Hemoglobin AC Control — Analytical Control Systems
- Hemoglobin AC Control Powder — Analytical Control Systems
- Hemoglobin AD Control — Analytical Control Systems
- Hemoglobin AE Control — Analytical Control Systems
- Hemoglobin AFSC Control — Analytical Control Systems
- Hemoglobin AS Control — Analytical Control Systems
- Hemoglobin F Abnormal Control — Analytical Control Systems
- Hemoglobin F Normal Control — Analytical Control Systems
- Hemoglobin FAS Control — Analytical Control Systems
- Hemoglobin G6PDH Deficient Control — Analytical Control Systems
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Analytical Control Systems
Sources (1)
- FDA UDI ae6bd74d-558f-46b3-86f7-8dfcaf5c7a00 34 fields · synced May 31, 2026