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Accustrip 10-Parameter Urine Reagent Strip

FDA UDI

Class I (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
Accustrip 10-Parameter Urine Reagent Strip FDA UDI
Generic Name
Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
10-Parameter Urine Reagent Strip For Use with Accustrip URS Reader Blood, Urobilinogen, Billirubin, Protein, Nitrite, Ketone, Glucose, pH, SG, Leukocytes FDA UDI
Model / Reference
UA870 FDA UDI
Description
10-Parameter Urine Reagent Strip For Use with Accustrip URS Reader Blood, Urobilinogen, Billirubin, Protein, Nitrite, Ketone, Glucose, pH, SG, Leukocytes FDA UDI

Identifiers

Catalog Number
00763924870103 FDA UDI
Primary DI / UDI-DI
10763924870100 FDA UDI
510(k) Number
K991927 FDA UDI
FDA Product Code
JRE FDA UDI
CDM FDA UDI
JIR FDA UDI
CEN FDA UDI
JMT FDA UDI
JIN FDA UDI
JJB FDA UDI
LJX FDA UDI
JIO 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
862.2800 FDA UDI
862.1785 FDA UDI
862.1645 FDA UDI
862.1550 FDA UDI
862.1510 FDA UDI
862.1435 FDA UDI
862.1115 FDA UDI
864.7675 FDA UDI
864.6550 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

Accustrip 10-Parameter Urine Reagent Strip 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

K991927 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jant Pharmacal Corp.

Sources (1)

  • FDA UDI 96a68ff2-0fb2-4e65-a17e-3f04a751b86c 35 fields · synced May 31, 2026