Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT ESTRADIOL REAGENT KIT 1 x 500 FDA UDI
- Model / Reference
- 7K72-35 FDA UDI
- Description
- ARCHITECT ESTRADIOL REAGENT KIT 1 x 500 FDA UDI
Identifiers
- Catalog Number
- 07K7235 FDA UDI
- Primary DI / UDI-DI
- 00380740106065 FDA UDI
- FDA Product Code
- CHP FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1260 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
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: Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Architect by Abbott Ireland — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay.
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- Dimension Vista® Flex® reagent cartridge E2 — Siemens Healthcare Diagnostics · Class I
- Atellica IM eE2 — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® eE2 — Siemens Healthcare Diagnostics · Class I
- iFlash-E2 — Shenzhen YHLO Biotech Co., Ltd. · Class I
- VITROS — Ortho-Clinical 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
- Abbott Ireland
Sources (1)
- FDA UDI 3f5168f8-f840-426f-8709-dfc36310b27c 36 fields · synced Jun 8, 2026