Identity
- Trade Name
- K-CHECK CONTROLS FDA UDI
- Generic Name
- Acetone IVD, control FDA UDI
- Device Name
- The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year. FDA UDI
Identifiers
- Catalog Number
- B1777 FDA UDI
- Primary DI / UDI-DI
- 00860009154025 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Acetone IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetone IVD, control
K-Check Controls by Biorex Labs LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Biorex Labs LLC
Sources (1)
- FDA UDI 3c08d985-5e2e-4197-8bc9-17d3ff57da6c 36 fields · synced May 30, 2026