← Back to catalogue

Accutest

FDA UDI

Class I (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
Accutest FDA UDI
Generic Name
Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes FDA UDI
Model / Reference
UA704A FDA UDI
Description
4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes FDA UDI

Identifiers

Primary DI / UDI-DI
10763924410146 FDA UDI
510(k) Number
K052719 FDA UDI
FDA Product Code
JMT FDA UDI
LJX FDA UDI
JIR FDA UDI
JIL FDA UDI
GMDN Term
Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1510 FDA UDI
864.7675 FDA UDI
862.1645 FDA UDI
862.1340 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: Urine catalase IVD, kit, rapid colorimetric, clinical

Accutest by Jant Pharmacal Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine catalase IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K052719 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Jant Pharmacal Corp.

Sources (1)

  • FDA UDI 5732af5b-8c41-4bbd-8ff7-168020a83710 34 fields · synced Jun 8, 2026