Identity
- Trade Name
- E. coli reference strain H38 FDA UDI
- Generic Name
- Escherichia coli antigen IVD, control FDA UDI
- Device Name
- Reference strain FDA UDI
- Model / Reference
- 85354 FDA UDI
- Description
- Reference strain FDA UDI
Identifiers
- Catalog Number
- 85354 FDA UDI
- Primary DI / UDI-DI
- 05713106853542 FDA UDI
- FDA Product Code
- GMZ FDA UDI
- GMDN Term
- Escherichia coli antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3255 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Escherichia coli antigen IVD, control
E. coli reference strain H38 by Ssi Diagnostica A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Escherichia coli antigen IVD, control.
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- E. coli reference strain O157 — Ssi Diagnostica A/S · Class I
- E. coli reference strain O39 — Ssi Diagnostica A/S · Class I
- E. coli reference strain O58 — Ssi Diagnostica A/S · Class I
- E. coli reference strain O59 — Ssi Diagnostica A/S · Class I
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
- Ssi Diagnostica A/S
Sources (1)
- FDA UDI 16832399-6fc9-47a8-8878-6eb6bb125ed5 36 fields · synced May 31, 2026