Identity
- Trade Name
- Hemoglobin Variant Control Kit FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, control FDA UDI
- Model / Reference
- HC-121 FDA UDI
Identifiers
- Catalog Number
- HC-121 FDA UDI
- Primary DI / UDI-DI
- 00817869020359 FDA UDI
- GMDN Term
- Inherited haemoglobinopathy 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
No
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
Yes
FDA UDI
Category: Inherited haemoglobinopathy IVD, control
Hemoglobin Variant Control Kit by Analytical Control Systems — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
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 |
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Manufacturer
- Manufacturer
- Analytical Control Systems
Sources (1)
- FDA UDI 0fc388ad-9c0b-4b3b-9144-99f9cb37c3c1 33 fields · synced May 30, 2026