# ICCBBA ISBT 128 Medical Device & Cellular Therapy UDI Spec
> Decode ICCBBA ISBT 128 medical and biologics identifiers for human cells, tissues, and cellular products.

- **Canonical URL:** https://stanzaapi.com/tools/udi-decoder/standard/iccbba-udi-format
- **Governing Standard:** FDA 21 CFR 801.20 / EU MDR 2017/745 (FDA AccessGUDID Database & IMDRF)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

## Technical Overview & Governing Rules
ICCBBA ISBT 128 is the globally recognized standard for the identification, labeling, and information transfer of medical products of human origin (MPHO).

## Specification Matrix
| Data Structure | Prefix | Description | Application |
| --- | --- | --- | --- |
| Donation Identification Number | =\ | Country, facility, year, and sequential number | Product traceability |
| Product Code | =< | Product description and attribute flags | Biologics classification |

## Standard JSON Response Model
```json
{
  "issuingAgency": "ICCBBA",
  "donationId": "W000026123456",
  "productCode": "E0398"
}
```

## Frequently Asked Questions & Edge Cases
### Q: When is ICCBBA required instead of GS1 or HIBCC?
**A:** ICCBBA ISBT 128 is specifically accredited for human cells, tissues, cellular and tissue-based products (HCT/Ps).