Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Homocysteine IVD, control FDA UDI
- Device Name
- Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine control.) FDA UDI
- Model / Reference
- 289 FDA UDI
- Description
- Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine control.) FDA UDI
Identifiers
- Catalog Number
- 289 FDA UDI
- Primary DI / UDI-DI
- 00847661004622 FDA UDI
- 510(k) Number
- K984071 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Homocysteine 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
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: Homocysteine IVD, control
Liquichek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, control.
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 — Carolina Liquid Chemistries Corp. · Class II
- Audit MicroControls Control LQ Homocysteine — Aalto Scientific, Ltd. · Class I
- Plasma Control Bi-Level — Chromsystems Instruments & Chemicals GmbH · Class I
- ARCHITECT — Abbott · Class II
- ADVIA Centaur® HCY MCM — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 — Carolina Liquid Chemistries Corp. · Class I
- Audit MicroControls Linearity LQ Homocysteine — Aalto Scientific, Ltd.
Cleared under the same submission
K984071 also covers:
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI aeca0438-38b5-440d-87d9-f50d38852794 37 fields · synced May 29, 2026