FDA.reportPublic FDA data

Testosterone Luminescence Immunoassay

Primary DI
04049325006546
Brand
Testosterone Luminescence Immunoassay
Company
IBL International GmbH
Model
RE62039.
Catalog number
RE62039.
Device description
Testosterone Luminescence Immunoassay - 10 x 96 Determinations
Published
2020-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
JITCalibrator, Secondary
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClinical Chemistry1
JITCalibrator, SecondaryClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033786000LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVAIbl GmbH2004-02-27JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049325006546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049325006546040493250065464049325006546

GMDN Terms#

Term, Definition table
TermDefinition
Total testosterone IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of total testosterone in a clinical specimen, using a chemiluminescent immunoassay 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
+49405328910IBL@Tecan.com

Regulatory Flags#

DUNS number
312694785
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049325034754DHEA ELISA30252873302528732025-04-30
0404932501235617beta-Estradiol Saliva Luminescence ImmunoassayRE62141RE621412020-12-29
0404932501236317beta-Estradiol Saliva Luminescence ImmunoassayRE62149RE621492020-12-29
04049325008304Active-B12 (Holotranscobalamin) ELISAAX53101AX531012016-09-24
0404932503362717-OH-Progesterone ELISA30223011302230112022-12-28
0404932503053417beta-Estradiol Saliva Luminescence ImmunoassayRE62141RE621412023-09-29
0404932503054117beta-Estradiol Saliva Luminescence ImmunoassayRE62149RE621492023-09-29
0404932503055817beta-Estradiol Saliva ELISA30121045301210452023-03-09
04049325001787DHEA-S ELISARE52181RE521812020-12-29
04049325014879Unassayed Testosterone QC Material30108902301089022020-12-29
0404932501721417beta-Estradiol Saliva ELISA30121045301210452020-12-29
04049325003545Testosterone Luminescence ImmunoassayRE62031RE620312020-10-20
04049325003606SaliCapsRE69991.RE69991.2020-12-29
04049325003613SaliCapsRE69995.RE69995.2020-12-29
04049325003521Progesterone Luminescence ImmunoassayRE62021RE620212020-12-29
04049325003538Progesterone Luminescence ImmunoassayRE62029RE620292020-12-29
04049325001404Acetylcholine Receptor Autoantibodies (ARAb) RRARE21021RE210212016-09-24
04049325001428Acetylcholine Receptor Autoantibodies (ARAb) RRARE21023RE210232016-09-24
04049325007727Cortisol Saliva Luminescence ImmunoassayRE62111RE621112016-09-24
04049325007734Cortisol Saliva Luminescence ImmunoassayRE62119RE621192016-09-24

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