Identity
- Trade Name
- Atellica™ IM ThCG DIL FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- HCG Total (ThCG) Diluent - Atellica IM - CONS - (2PK) 2 x 25mL FDA UDI
- Model / Reference
- 10995691 FDA UDI
- Description
- HCG Total (ThCG) Diluent - Atellica IM - CONS - (2PK) 2 x 25mL FDA UDI
Identifiers
- Catalog Number
- 10995691 FDA UDI
- Primary DI / UDI-DI
- 00630414600048 FDA UDI
- 510(k) Number
- K172322 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
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
Atellica™ IM ThCG DIL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered sample diluent IVD.
- C & S Diluent — Precision Biologic · 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
- IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Diluent — Biogenex Laboratories, Inc. · Class I
- IMMULITE®/IMMULITE® 1000 Systems CRP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 Systems HCY Homocysteine Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K172322 also covers:
- Atellica IM ThCG — Siemens Healthcare Diagnostics
- Atellica™ IM ThCG — Siemens Healthcare Diagnostics
- Atellica™ IM ThCG — Siemens Healthcare Diagnostics
- Atellica™ IM ThCG DIL — Siemens Healthcare Diagnostics
- Atellica™ IM ThCG DIL — Siemens Healthcare Diagnostics
- Atellica™ IM ThCG MCM — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 49940d2b-9376-460d-83fa-2c9a151ff095 37 fields · synced Jun 1, 2026