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Microbumin Microalbumin Control Level 1&2 Set 10x7mL
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Microbumin Microalbumin Control Level 1&2 Set 10x7mL FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- The Microbumin Microalbumin Control is intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples. It is supplied in two levels, 5x7mL each level per box. They are ready-to-use, liquid, requiring no reconstitution. They are prepared from human urine, fortified to target levels with human albumin and creatinine. Preservatives have been added to inhibit microbial growth. FDA UDI
- Model / Reference
- 1250-01 FDA UDI
- Description
- The Microbumin Microalbumin Control is intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples. It is supplied in two levels, 5x7mL each level per box. They are ready-to-use, liquid, requiring no reconstitution. They are prepared from human urine, fortified to target levels with human albumin and creatinine. Preservatives have been added to inhibit microbial growth. FDA UDI
Identifiers
- Catalog Number
- 1250-01 FDA UDI
- Primary DI / UDI-DI
- 00896863002103 FDA UDI
- 510(k) Number
- K831526 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte 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
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
Category: Multiple urine analyte IVD, control
Microbumin Microalbumin Control Level 1&2 Set 10x7mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, control.
- URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Mission Liquid Urine Controls — ACON Laboratories, Inc. · Class I
- Urine Chemistry Control Bi-Level — CLINIQA CORPORATION · Class I
- iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
- ABX PENTRA URINE CONTROL L/H — Horiba Abx · Class I
- K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- qUAntify — Bio-Rad Laboratories · Class I
Cleared under the same submission
K831526 also covers:
- Pointe Scientific, Inc. Microalbumin Controls — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Urine Chemistry Controls — POINTE SCIENTIFIC, INC.
- Dropper Urine Chemistry Control Level 1 Set 3x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 1 Set 3x25mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 1&2 Set 2x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 2 Set 3x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 2 Set 3x25mL — QUANTIMETRIX CORP.
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
- Quantimetrix Corp.
Sources (1)
- FDA UDI 49dba34f-b5f6-4107-bf89-a2798032273f 37 fields · synced Jun 8, 2026