Identity
- Trade Name
- Clinitek Atlas® Rinse Additiive FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas® automated urine chemistry system FDA UDI
- Model / Reference
- 10311113 FDA UDI
- Description
- Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas® automated urine chemistry system FDA UDI
Identifiers
- Catalog Number
- 5007A FDA UDI
- Primary DI / UDI-DI
- 00630414372464 FDA UDI
- 510(k) Number
- K932674 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 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 wash solution IVD
Clinitek Atlas® Rinse Additiive by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD.
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- VENTANA HE 600 Wash — Ventana Medical Systems · Class I
- TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
- COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
- ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
- V8 Maintenance Buffer Kit — Helena Laboratories, Corp. · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- cobas® Sample Prep Buffer — Roche Molecular Systems, Inc. · Class I
Cleared under the same submission
K932674 also covers:
- CLINITEK Atlas® Control+ Strips — Siemens Healthcare Diagnostics
- CLINITEK Atlas® Control- Strips. — Siemens Healthcare Diagnostics
- Clinitek Atlas® 10 Reagent PAK for Urine Chemistry — Siemens Healthcare Diagnostics
- Clinitek Atlas® Calibration Kit — Siemens Healthcare Diagnostics
- Clinitek Atlas® Calibrator #4 — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI e7778c74-aa15-4312-ab95-4bbd41cfcef0 37 fields · synced Jun 8, 2026