Identity
- Trade Name
- Fort Worth Diagnostics FDA UDI
- Generic Name
- Ehrlichia chaffeensis nucleic acid IVD, control FDA UDI
- Device Name
- Ehrlichia Control 5E4 cp/mL FDA UDI
- Model / Reference
- EHRPOS FDA UDI
- Description
- Ehrlichia Control 5E4 cp/mL FDA UDI
Identifiers
- Catalog Number
- EHRPOS FDA UDI
- Primary DI / UDI-DI
- 00850051429615 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Ehrlichia chaffeensis nucleic acid 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
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: Ehrlichia chaffeensis nucleic acid IVD, control
Fort Worth Diagnostics by Fort Worth Diagnostics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ehrlichia chaffeensis nucleic acid IVD, control.
- Exact Diagnostics — Exact Diagnostics · 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
- Fort Worth Diagnostics Llc
Sources (1)
- FDA UDI 5fa608d8-e617-41dc-9e9f-6f5a9ec911d8 35 fields · synced May 31, 2026