FDA.reportPublic FDA data

TRUE® 20 PLUS hCG

Primary DI
00657498001400
Brand
TRUE® 20 PLUS hCG
Company
STANBIO LABORATORY, L.P.
Model
1440-025
Catalog number
1440-025
Device description
A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Serum or Urine.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498001400PrimaryGS10
00657498001417Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001400006574980014006574980014000657498001400
00657498001417006574980014176574980014170657498001417

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00657498002094Uri-Trak 120 M Urine AnalyzerG1300-001G1300-0012023-06-08
00657498002322HGB Controls - Low3061-0033061-0032021-03-31
00657498002339HGB Controls - Low3061-0063061-0062021-03-31
00657498002346HGB Controls - Normal3062-0033062-0032021-03-31
00657498002353HGB Controls - Normal3062-0063062-0062021-03-31
00657498002360HGB Controls - High3063-0033063-0032021-03-31
00657498002377HGB Controls - High3063-0063063-0062021-03-31
00657498001806Standard 1A469-97A469-972016-09-24
00657498000199HemoPoint H2 DMSG3500-001G3500-0012016-09-24
00657498000380Excel® Chemistry AnalyzerG7700E-001G7700E-0012018-04-17
00657498000397Excel® Chemistry Analyzer (Spanish)G7700S-001G7700S-0012018-04-17
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18

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Primary DI, Brand, Company table
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10612479279862McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
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00850035206126ProovMfb Fertility, Inc.JHI2023-03-28
00850035206003ProovMfb Fertility, Inc.JHI2023-03-24
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10894175000081OneStepDiagnostic Automation, Inc.JHI2021-08-11
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