Identity
- Trade Name
- APTIMA® FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Aptima® Specimen Diluent. FDA UDI
- Model / Reference
- KIT SPECIMEN DILUENT VIRL LOAD ASY APTIMA US IVD FDA UDI
- Description
- Aptima® Specimen Diluent. FDA UDI
Identifiers
- Catalog Number
- PRD-03503 FDA UDI
- Primary DI / UDI-DI
- 15420045504240 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 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
No
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: Buffered sample diluent IVD
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered sample diluent IVD.
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- Dimension® Sample Diluent — Siemens Healthcare Diagnostics · Class II
- IMMULITE®/IMMULITE® 1000 Systems DHS DHEASO4 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Lumipulse G Specimen Diluent 2 — FUJIREBIO INC. · Class I
- ADVIA Centaur® T4 DIL — Siemens Healthcare Diagnostics · Class II
- Dimension® Purified Water Diluent — Siemens Healthcare Diagnostics · Class I
- IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
BP150318 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI aaa3ba38-3c9b-4f26-93de-c43439253eba 37 fields · synced Jun 8, 2026