ARCHITECT 06S6001

GUDID 00380740193720

AdviseDx SARS-CoV-2 IgG II Calibrator Kit

Abbott Ireland Diagnostics

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

• Primary Device ID: 00380740193720
• NIH Device Record Key: 68bc889b-708f-481d-b499-b4e9bd09e64c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 06S6001
• Catalog Number: 06S6001
• Company DUNS: 985307301
• Company Name: Abbott Ireland Diagnostics
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740193720 [Primary]

FDA Product Code

• QKO: Reagent, coronavirus serological

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: 2021-04-14
• Device Publish Date: 2021-04-06

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• 00380740112400: ARCHITECT AFP Reagent Kit
• 00380740105433: ARCHITECT AUSAB Reagent
• 00380740105426: ARCHITECT AUSAB Reagent
• 00380740105419: ARCHITECT AUSAB Controls
• 00380740105402: ARCHITECT AUSAB Calibrators
• 00380740081317: ARCHITECT AFP Reagent Kit
• 00380740081294: ARCHITECT AFP Controls
• 00380740081287: ARCHITECT AFP Calibrators
• 00380740014582: ARCHITECT CEA Reagent kit
• 00380740014575: ARCHTECT CEA Reagent kit
• 00380740014551: ARCHITECT CEA Controls
• 00380740014544: ARCHITECT CEA Calibrators
• 00380740013066: ARCHITECT Multi -Assay Manual Diluent
• 00380740009786: ARCHITECT PRE TRIGGER SOLUTION
• 00380740009625: ARCHITECT TRIGGER SOLUTION
• 00380740009618: ARCHITECT CONCENTRATED WASH BUFFER (10L)
• 00380740009601: ARCHITECT CONCENTRATED WASH BUFFER
• 00380740009021: ARCHITECT Free PSA Reagent Kit
• 00380740009014: ARCHITECT Free PSA Controls
• 00380740009007: ARCHITECT Free PSA Calibrators
• 00380740008994: ARCHITECT Total PSA Reagent Kit
• 00380740008987: ARCHITECT Total PSA Reagent Kit
• 00380740008970: ARCHITECT Total PSA Controls
• 00380740008963: ARCHITECT Total PSA Calibrators
• 00380740007805: ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent
• 00380740007799: ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit
• 00380740007782: ARCHITECT HBsAg Qualitative Reagent Kit
• 00380740007775: ARCHITECT HBsAg Qualitative Reagent Kit
• 00380740007768: ARCHITECT HBsAg Qualitative Controls
• 00380740007751: ARCHITECT HBsAg Qualitative Calibrators
• 00380740001520: ARCHITECT AUSAB Reagent Kit
• 00380740001513: ARCHITECT AUSAB Reagent Kit
• 00380740001506: ARCHITECT AUSAB Controls
• 00380740001490: ARCHITECT AUSAB Calibrators
• 00380740001193: ARCHITECT Probe Conditioning Solution
• 00380740193782: AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test
• 00380740193768: AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test
• 00380740193744: AdviseDx SARS-CoV-2 IgG II Control Kit
• 00380740193720: AdviseDx SARS-CoV-2 IgG II Calibrator Kit
• 00380740208486: ARCHITECT HBsAg Next Qualitative Calibrators
• 00380740208479: ARCHITECT HBsAg Next Confirmatory Manual Diluent
• 00380740208462: ARCHITECT HBsAg Next Qualitative Controls
• 00380740163389: ARCHITECT HBsAg Next Qualitative Reagent Kit (2000T)
• 00380740158187: ARCHITECT HBsAg Next Confirmatory Reagent Kit (100T)
• 00380740157012: ARCHITECT HBsAg Next Qualitative Reagent Kit (500T)
• 00380740156992: ARCHITECT HBsAg Next Qualitative Reagent Kit (100T)