FDA.reportPublic FDA data

BioCheck T3 EIA Test Kit

Primary DI
00850392007053
Brand
BioCheck T3 EIA Test Kit
Company
BIOCHECK, INC.
Model
BC-1005
Catalog number
BC-1005
Device description
The BioCheck T3 EIA Test Kit is intended for the quantitative determination of triiodothyronine (T3) concentration in human serum.
Published
2019-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDPRadioimmunoassay, Total Triiodothyronine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDPRadioimmunoassay, Total TriiodothyronineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991311000TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.1999-06-02CDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850392007053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850392007053008503920070538503920070530850392007053

GMDN Terms#

Term, Definition table
TermDefinition
Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(650)573-1968info@biocheckinc.com

Regulatory Flags#

DUNS number
171857493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850392007015BioCheck TSH EIA Test KitBC-1001BC-10012019-10-08
00850392007039BioCheck U-TSH EIA Test KitBC-1003BC-10032019-10-08
00850392007077BioCheck T4 EIA Test KitBC-1007BC-10072019-10-08
00850392007176BioCheck Myoglobin EIA Test KitBC-1117BC-11172019-10-08
00850392007190BioCheck High Sensitive CRP EIA Test KitBC-1119BC-11192019-10-08
00850392007251BioCheck Human Ferritin EIA Test KitBC-1025BC-10252019-10-08
00850392007275BioCheck hCG EIA Test KitBC-1027BC-10272019-10-08
00850392007350BioCheck IgE EIA Test KitBC-1035BC-10352019-10-08
00850392007619BioCheck Beta-2 Microglobulin EIA Test KitBC-1061BC-10612019-10-08
00850392007152BioCheck Testosterone EIA Test KitBC-1115BC-11152019-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026446AccuDiag™ T3 ELISA KitDiagnostic Automation, Inc.CDP2026-03-02
14562185395447CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
00840239023858Free Triiodothyronine (fT3) ELISADRG International IncCDP2024-09-23
00840239038012Free T3 ELISADRG International IncCDP2024-09-23
00840239053565T3 freeDRG International IncCDP2024-09-23
04048474023855Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474038019Free T3 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474053562T3 freeDRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
00840239056979T-3DRG International IncCDP2024-08-13
04048474056976T-3DRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-08-13
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CDP2024-07-22
04048474052756Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474052770Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474041071Free Triiodothyronine (fT3) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474045697T3 Total ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474017809Triiodothyronine (T3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-29
00840239045690T3 Total ELISA DRG International IncCDP2023-08-25
00840239052759Total Triiodothyronine (tT3) ELISADRG International IncCDP2023-08-25
15099590201661Access Free T3Beckman Coulter, Inc.CDP2023-06-26
15099590227210Access Total T3Beckman Coulter, Inc.CDP2023-06-26
00894175000886AccuDiag ™Diagnostic Automation, Inc.CDP2023-06-14
00850049545976QmedixDiagnostic Automation, Inc.CDP2023-06-13
10758750033782VITROSORTHO CLINICAL DIAGNOSTICSCDP2023-03-28
04049016139232Free Triiodothyronine (FT3) ELISAEUROIMMUN Medizinische Labordiagnostika AGCDP2022-12-08
06925912718505iFlash-T3Shenzhen YHLO Biotech Co., Ltd.CDP2022-10-26
07613336171578Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171585Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171646Elecsys T3Roche Diagnostics GmbHCDP2021-08-13
07613336171653Elecsys T3Roche Diagnostics GmbHCDP2021-08-13