ACON SARS-CoV-2 IgG/IgM Rapid Test 200979

GUDID 20682607200973

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)

ACON LABORATORIES, INC.

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Primary Device ID20682607200973
NIH Device Record Key6244f1ab-86ac-4a61-ae08-470358c4c934
Commercial Distribution StatusIn Commercial Distribution
Brand NameACON SARS-CoV-2 IgG/IgM Rapid Test
Version Model NumberL031-11711
Catalog Number200979
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count25
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607002269 [Unit of Use]
GS100682607200979 [Primary]
GS120682607200973 [Package]
Contains: 00682607200979
Package: Carton [45 Units]
In Commercial Distribution

FDA Product Code

QKOReagent, coronavirus serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

Devices Manufactured by ACON LABORATORIES, INC.

10682607630308 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
10682607630544 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
20682607630558 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
20682607651256 - HealthyMe UTI Urinary Tract Infection Test Strips2024-04-04 Urinary Tract Infection home test with handle
20682607200508 - MISSION U500 URINE ANALYZER2024-03-18 URINE ANALYZER
20682607200515 - MISSION U500 URINE ANALYZER2024-03-18 URINE ANALYZER with Barcode Reader
20682607660272 - Flowflex COVID-19 Antigen Home Test2021-11-30 Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
20682607660289 - Flowflex COVID-19 Antigen Home Test2021-11-30 Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.