Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Myoglobin IVD, control FDA UDI
- Device Name
- ARCHITECT STAT Myoglobin Controls FDA UDI
- Model / Reference
- 2K43-10 FDA UDI
- Description
- ARCHITECT STAT Myoglobin Controls FDA UDI
Identifiers
- Catalog Number
- 02K4310 FDA UDI
- Primary DI / UDI-DI
- 00380740003289 FDA UDI
- 510(k) Number
- K013995 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Myoglobin IVD, control 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
Yes
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: Myoglobin IVD, control
Architect by Abbott Ireland Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Myoglobin IVD, control.
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- Myoglobin Control Set — Roche Diagnostics Corp. · Class I
- Myoglobin control slides — BIO SB, INC. · Class I
- Myoglobin control slides — BIO SB, INC. · Class I
- ADVIA Centaur® MYO MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K013995 also covers:
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
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 783aa71d-bbbe-4e54-8780-44fb2fb7c9e8 37 fields · synced Jun 8, 2026