FDA.reportPublic FDA data

AutoUA®

Primary DI
00854080008643
Brand
AutoUA®
Company
Sciteck Diagnostics, Inc.
Model
217-S
Catalog number
217-S
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
00854080008643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854080008643008540800086438540800086430854080008643

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide (CO2) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.

Contacts#

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

Regulatory Flags#

DUNS number
041137964
Device count
1
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
00854080008650AutoUA®200-120200-1202026-04-07