Identity
- Trade Name
- Matrix Plus Cholestereol Reference Kit FDA UDI
- Generic Name
- Multiple clinical chemistry protein IVD, calibrator FDA UDI
- Device Name
- Calibrator / Calibration Verifier FDA UDI
- Model / Reference
- 9550 FDA UDI
- Description
- Calibrator / Calibration Verifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852553007018 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
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: Multiple clinical chemistry protein IVD, calibrator
Matrix Plus Cholestereol Reference Kit 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 Chemistry Reference, Level F — 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 439206bd-f1a6-4eb3-b00b-de3e5923086f 36 fields · synced May 30, 2026