Identity
- Trade Name
- Mission Plus Hemoglobin (Hb) Control Solution Kit FDA UDI
- Generic Name
- Haemoglobin analyser IVD, point-of-care FDA UDI
- Device Name
- 2mL bottles of Level 0, Level 1, Level 2 FDA UDI
- Model / Reference
- C122-3041 FDA UDI
- Description
- 2mL bottles of Level 0, Level 1, Level 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00682607200023 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Haemoglobin analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Haemoglobin analyser IVD, point-of-care
Mission Plus Hemoglobin (Hb) Control Solution Kit by ACON Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin analyser IVD, point-of-care.
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- HemoCue® Hb 201 Microcuvettes — Hemocue, Inc. · Class II
- HemoCue® Hb301 Analyzer — Hemocue, Inc. · Class II
- HemoCue® Hb301 Analyzer — Hemocue, Inc. · Class II
- DiaSpect Tm — EKF-diagnostic GmbH · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- HemoCue® Hb 201 Microcuvettes — Hemocue, Inc. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- ACON Laboratories, Inc.
Sources (1)
- FDA UDI 39c222fb-0966-455d-85f9-381957debb8f 35 fields · synced Jun 9, 2026