Manufacturer Profile
Acon Laboratories, Inc. Registered Devices
Listing registered devices, PMA filings, and compliance records for Acon Laboratories, Inc..
gudid
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G115-10D
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gudid
1 Test per kit (L03A-R1445):Test Cassette (1), Extraction Buffer Tube (1), Swab Guard (1), Nasal Swab (1); 2 Test per kit (L03A-R1545): Test Cassettes (2), Extraction Buffer Tubes (2), Swab Guards (2), Nasal Swabs (2); 5 Test per kit (L03A-R1645): Test Cassettes (5), Extraction Buffer Tubes (5), Swab Guards (5), Nasal Swabs (5); 25 Test per kit (L03A-R1745): Test Cassettes (25), Extraction Buffer Tubes (25), Swab Guards (25), Nasal Swabs (25)
ID: L03A-R1445, L03A-R1545, L03A-R1645, L03A-R1745
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gudid
25 Test per kit (L03A-R0115):Test Cassettes (27), Test Tubes (27), Dropper Tips (27), Throat Swabs (27), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1)
ID: L03A-R0115
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gudid
1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
ID: L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
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gudid
Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers
ID: C112-3061
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gudid
Box of 50 Test Cartridges (5 vials of 10) and 60 Capillary Transfer Tubes (3 bags of 20)
ID: C132-3041
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gudid
Blood Glucose Meter, 10 test strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G117-10A
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gudid
Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G117-108
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gudid
Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2
ID: G125-12L
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gudid
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G115-107
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gudid
Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2
ID: G125-12D
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gudid
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G115-102
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gudid
Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G115-10S
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gudid
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
ID: G113-111
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gudid
1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L031-125N5): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L031-125P5): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
ID: L031-118B5, L031-125M5, L031-125N5, L031-125P5
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gudid
2mL Control Solution 0 (1), 2mL Control Solution 1 (1), 2mL Control Solution 2 (1), Package Insert (1)
ID: OGC-511
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