Alinity 09P3720

GUDID 00380740156336

Alinity i DHEA-S Reagent Kit 200 Tests

Abbott GmbH & Co. KG

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00380740156336
• NIH Device Record Key: 9520adfe-2420-4f34-9343-ac5d8d4f0b79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity
• Version Model Number: 09P3720
• Catalog Number: 09P3720
• Company DUNS: 315786293
• Company Name: Abbott GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740156336 [Primary]

FDA Product Code

• JKC: RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-19
• Device Publish Date: 2019-04-11

On-Brand Devices [Alinity]

• 00380740166441: Alinity c Lithium Assay File
• 00380740162832: Alinity c Bili Total Assay File
• 00380740161941: Alinity c UIBC Assay File
• 00380740160807: Alinity i B_hCG Assay File
• 00380740160791: Alinity c Iron Assay File
• 00380740158460: Alinity ci-series Reagent Cartridge, Black (Large)
• 00380740158422: Alinity c Total Bilirubin Reagent Kit 3600 Tests
• 00380740158415: Alinity c Total Bilirubin Reagent Kit 2750 Tests
• 00380740155919: Alinity i CA 19-9XR Reagent Kit 200 Tests
• 00380740155797: Alinity i tHCY-DIL Assay File
• 00380740154493: Alinity i C-Peptide Reagent Kit 200 Tests
• 00380740154486: Alinity i Homocysteine Controls
• 00380740154479: Alinity i Homocysteine Calibrators
• 00380740154462: Alinity i C-Peptide Calibrators
• 00380740154325: Alinity c Lipid Multiconstituent Calibrator Kit
• 00380740153526: Alinity i C-Peptide Controls
• 00380740153496: Alinity i Homocysteine Reagent Kit 200 Tests
• 00380740153458: Alinity c-series Detergent B
• 00380740152864: Alinity c Iron Calibrator Kit
• 00380740152123: Alinity c Valproic Assay File
• 00380740152109: Alinity c Tobra Assay File
• 00380740152093: Alinity c Theo Assay File
• 00380740152062: Alinity c Prealbumin Assay File
• 00380740152055: Alinity c Phenobarb Assay File
• 00380740151843: Alinity c ASO Assay File
• 00380740151812: Alinity c Amikacin Assay File
• 00380740151799: Alinity c a1AT Assay File
• 00380740151768: Alinity c B2M Assay File
• 00380740151737: Alinity i SHBG Assay File
• 00380740151706: Alinity i Progest Assay File
• 00380740151690: Alinity i PCT Assay File
• 00380740151621: Alinity i LH Assay File
• 00380740151614: Alinity i Insulin Assay File
• 00380740151607: Alinity i tHCY-UNDIL Assay File
• 00380740151553: Alinity i FSH Assay File
• 00380740151485: Alinity i C-Peptide Assay File
• 00380740151447: Alinity i VitB12 Assay File
• 00380740151430: Alinity i Anti-TPO Assay File
• 00380740151423: Alinity i Anti-Tg Assay File
• 00380740151416: Alinity i Anti-CCP Assay File
• 00380740151393: Alinity i SHBG Reagent Kit
• 00380740151386: Alinity i SHBG Controls
• 00380740151379: Alinity i SHBG Calibrators
• 00380740151362: Alinity i Anti-CCP Reagent Kit 200 Tests
• 00380740151355: Alinity i Anti-CCP Controls
• 00380740151348: Alinity i Anti-CCP Calibrators
• 00380740151256: Alinity c Prealbumin Calibrator Kit
• 00380740151089: Alinity c Specific Proteins Multiconstituent Calibrator Kit
• 00380740150914: Alinity i Testo 2G Assay File
• 00380740150815: Alinity i Insulin Reagent Kit 200 Tests