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Dropper Spinal Fluid Control Level 1&2 Set 2x3mL

FDA UDI

Class I (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name
Dropper Spinal Fluid Control Level 1&2 Set 2x3mL FDA UDI
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Device Name
The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. FDA UDI
Model / Reference
1450-01 FDA UDI
Description
The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. FDA UDI

Identifiers

Catalog Number
1450-01 FDA UDI
Primary DI / UDI-DI
00896863002073 FDA UDI
510(k) Number
K831527 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Multiple-type clinical chemistry analyte profile 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-type clinical chemistry analyte profile IVD, controlMultiple clinical chemistry protein IVD, control

Dropper Spinal Fluid Control Level 1&2 Set 2x3mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry protein IVD, control.

Cleared under the same submission

K831527 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quantimetrix Corp.

Sources (1)

  • FDA UDI 8aaeeedd-1a1b-48b2-9f20-7032b468f15b 37 fields · synced May 30, 2026