FDA.reportPublic FDA data

PEARL DENT CO., LTD.

Matched from indexed company URL: Pearl, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036370553003637055PEARL DENT CO., LTD.1N2026-01-01LOT III -15B STREET NO.13 TAN BINH INDUSTRIAL PARK, TAY THANH WARD HOCHIMINH CITY Ho Chi Minh VN 700000
30112796063011279606PEARLTEC USA INC1Y2026-01-01200 Continental Dr Ste 401 Newark DE US 19713
30129018013012901801PEARL TECHNOLOGY AG1N2026-01-01Wiesenstrasse 33 Schlieren Zurich CH 8952
30218875663021887566PEARL INC.1N2026-01-019200 W Sunset Blvd Ste 430 West Hollywood CA US 90069
30229296183022929618PEARL DIAGNOSTICS, INC.1N2026-01-011812 Ashland Ave Ste G32 Baltimore MD US 21205
30337157243033715724PEARL SHINE LLC1Y2026-01-01108 Commercial Circle Suite 802 Conroe TX US 77304
30425347683042534768PEARLYFLOSS LLC.1N2026-01-01515 West 18th Street Apt 602 New York NY US 10011

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860009979543MycoMEIA Aspergillus Assay - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates.+1-317-413-3465info@pearldx.com
00860009979550MycoMEIA Aspergillus Assay Sample Processing Columns - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. Urine is first processed through Sample Processing Columns to eliminate an inhibitor of antibody-antigen recognition.+1-317-413-3465info@pearldx.com
00860009979567MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. 25X Concetrated Wash solution is diluted to wash the asssay plates.+1-317-413-3465info@pearldx.com
00860009979574MycoMEIA Aspergillus Assay Uncoated Plates - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. Uncoated plates are used to fill in empty spaces if a partial assay plate is being used.+1-317-413-3465info@pearldx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3034911000011888K250525Second Opinion® PanoramicMYN2025-11-14
3034911062964000K243989Second Opinion® 3DQIH2025-05-23
3034911627860289K243893Second Opinion® PediatricMYN2025-05-05
3110901100067635K243496MycoMEIA Aspergillus AssayNOM2025-08-01
3034912062363796K243234Second Opinion® CSMYN2025-06-12
3034911674831911K243230Second Opinion® BLEQIH2025-05-09
3034911326660561K242600Second Opinion Periapical Radiolucency ContoursMYN2025-04-11
3034911726314026K242522Second Opinion CCMYN2025-01-16
3034911912404115K210365Second OpinionMYN2022-03-04
603301022786908
2015901154542329
603301214188211
3110901305966699
2015901351438851
603301398777141
2015901633354647
2015901913705411
2015901917266059
3467542024888705

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MYN62025-11-14
QIH22025-05-23
NOM12025-08-01

NDC#

PMN#

GUDID#

MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. 25X Concetrated Wash solution is diluted to wash the asssay plates.

Pearl Diagnostics

2026-03-16

MycoMEIA Aspergillus Assay Sample Processing Columns - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. Urine is first processed through Sample Processing Columns to eliminate an inhibitor of antibody-antigen recognition.

Pearl Diagnostics

2026-03-16

MycoMEIA Aspergillus Assay Uncoated Plates - The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. Uncoated plates are used to fill in empty spaces if a partial assay plate is being used.

Pearl Diagnostics

2026-03-16

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