Identity
- Trade Name
- Carbon Dioxide Standard Kit FDA UDI
- Generic Name
- Carbon dioxide (CO2) IVD, calibrator FDA UDI
- Device Name
- Calibrator / Calibration Verifier FDA UDI
- Model / Reference
- 9210 FDA UDI
- Description
- Calibrator / Calibration Verifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852553007100 FDA UDI
- 510(k) Number
- K112834 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Carbon dioxide (CO2) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 75 Milliliter FDA UDI
Category: Carbon dioxide (CO2) IVD, calibrator
Carbon Dioxide Standard Kit by Verichem Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide (CO2) IVD, calibrator.
- Atellica CH CO2 Calibrator — Siemens Healthcare Diagnostics · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
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- Yumizen C1200 CO2 Cal — Horiba Abx · Class II
- Alinity — Abbott · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- ARCHITECT — Abbott · Class II
- ABX PENTRA CO2 CAL — Horiba Abx · Class II
Cleared under the same submission
K112834 also covers:
- Carbon Dioxide Standard — VERICHEM LABORATORIES, INC.
- Carbon Dioxide Standard, Level F — VERICHEM LABORATORIES, INC.
- Electrolyte Standard Kit — VERICHEM LABORATORIES, INC.
- Serum ISE Standard Kit — VERICHEM LABORATORIES, INC.
- Serum ISE Verifier Kit — VERICHEM LABORATORIES, INC.
- Urine Chemistry Standard Kit — VERICHEM LABORATORIES, INC.
- Urine Uric Acid Standard Kit — VERICHEM LABORATORIES, INC.
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
- Verichem Laboratories, Inc.
Sources (1)
- FDA UDI 32b47dc6-825f-4e67-ae1d-b0b2ec209bdf 36 fields · synced May 30, 2026