GDS ACETASITE/STAT-SITE SYSTEM

Company Name GDS TECHNOLOGY, DIVISION OF STANBIO LABORATORY
Address 25235 LEER DR.
City, State / Province, ZIP / Postal Code ELKHART, IN 46514
Country US
FDA Owner/Operator Phone 830-249-0772
FDA Medical Specialty Code TX - Clinical Toxicology
FDA Product Code LDP
FDA Classification Name COLORIMETRY, ACETAMINOPHEN
FDA Device Classification Code Standards
FDA Regulation Number 862.3030
FDA Common Generic Name BLOOD ACETAMINOPHEN TEST SYSTEM
FDA Proprietary Device Name GDS ACETASITE/STAT-SITE SYSTEM
FDA Owner / Operator Number 1616487
FDA Owner / Operator Name STANBIO LABORATORY
FDA Establishment Registration Number 1832837
FDA Registered Establishment Name GDS TECHNOLOGY, DIVISION OF STANBIO LABORATORY
FDA Operation Code(s) MM - Manufacturer
MR - Remanufacturer
RR - Repackager/Relabeller

Competitors of GDS TECHNOLOGY, DIVISION OF STANBIO LABORATORY

Our records indicate that the following medical device companies may manufacture a similar device.

  Company Name Proprietary Device Name Common Generic Device Name
1 ABBOTT LABORATORIES MULTIPLE: AXSYM, TDX/TDX FLX/ADX ACETAMINOPHLEN VARIOUS ACETAMENOPHEN ASSAYS
2 BECKMAN COULTER, INC. MULTIPLE VARIOUS
3 BECKMAN COULTER, INC. MULTIPLE VARIOUS
4 BIOSITE INCORPORATED TRIAGE TOX DRUG SCREEN FLUORESCENCE IMMUNOASSAY FOR DETECTION OF DRUGS OF ABUSE IN URINE
5 CAROLINA LIQUID CHEMISTRIES CORP. ACET ACETAMINOPHEN REAGENT
6 DADE BEHRING, INC. ACA R ACETAMINOPHEN ACTMN ANALYTICAL TEST PACK ACA R ACETAMINOPHEN ACTMN ANALYTICAL TEST PACK
7 DIAGNOSTIC CHEMICALS LTD. ACETAMINOPHEN ASSAY ACETAMINOPHEN ASSAY
8 ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS ACETAMINOPHEN SLIDE ACETAMINOPHEN TEST SYSTEM
9 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MULTIPLE MULTIPLE


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