AutoUA®

Primary DI
00854080008650
Brand
AutoUA®
Company
Sciteck Diagnostics, Inc.
Model
200-120
Catalog number
200-120
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935408000
K950142000
K951877000
K954514000
K970087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935408000UA PERFECTChimera Research & Chemical, Inc.1994-06-13KQO
K950142000CR PERFECTChimera Research & Chemical, Inc.1995-05-25CGX
K951877000AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINEChimera Research & Chemical, Inc.1996-05-14KQO
K954514000UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINESciteck Diagnostics, Inc.1996-06-21KQO
K970087000CR PERFECTChimera Research & Chemical, Inc.1997-03-06CGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854080008650PrimaryGS10
00854080008667Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854080008650008540800086508540800086500854080008650
00854080008667008540800086678540800086670854080008667

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Contacts#

Phone, Email table
PhoneEmail
800-749-4537Info@sciteck.org

Regulatory Flags#

DUNS number
041137964
Device count
1000
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854080008612SciteckAUA-450AUA-4502026-04-07
00854080008629AutoUA® 200-60200-602026-04-07
00854080008643AutoUA®217-S217-S2026-04-07