Identity
- Trade Name
- Matrix Plus Chemistry Reference, Level F FDA UDI
- Generic Name
- Multiple clinical chemistry protein IVD, calibrator FDA UDI
- Device Name
- Calibrator / Calibration Verifier FDA UDI
- Model / Reference
- 9506 FDA UDI
- Description
- Calibrator / Calibration Verifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852553007339 FDA UDI
- 510(k) Number
- K901113 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Multiple clinical chemistry protein 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
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: Multiple clinical chemistry protein IVD, calibrator
Matrix Plus Chemistry Reference, Level F by Verichem Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple clinical chemistry protein IVD, calibrator.
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Cleared under the same submission
K901113 also covers:
- Chemistry 1 Install Standard Kit — VERICHEM LABORATORIES, INC.
- Chemistry 2 Install Standard Kit — VERICHEM LABORATORIES, INC.
- Chemistry 3 Install Verifier Kit — VERICHEM LABORATORIES, INC.
- Chemistry Reference Kit — VERICHEM LABORATORIES, INC.
- Matrix Plus Chemistry Reference Kit — VERICHEM LABORATORIES, INC.
- Matrix Plus Cholestereol Reference Kit — VERICHEM LABORATORIES, INC.
- Matrix Plus Cholesterol, Level F — VERICHEM LABORATORIES, INC.
- Urea Nitrogen / Creatinine 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 |
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Manufacturer
- Manufacturer
- Verichem Laboratories, Inc.
Sources (1)
- FDA UDI b9f4553e-247b-4e4e-afc1-e0d2947bfe81 35 fields · synced Jun 6, 2026