Na 303-12

by Alta Diagnostics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number30858512007052 UDI-DI	Date29 Mar 2019Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Multiple urine analyte IVD, control
Model / Ref / Catalog: 303-12

Primary DI / UDI-DI: 30858512007052
510(k) Number: K890577
FDA Product Code: JJW
GMDN Term: Multiple urine analyte IVD, control

Device Class: Class I
Regulation Number: 862.1660
GUDID distribution status: In Commercial Distribution

Size: Total Volume — 30 Milliliter

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No