FDA.reportPublic FDA data

Unassayed Testosterone QC Material

Primary DI
04049325014879
Brand
Unassayed Testosterone QC Material
Company
IBL International GmbH
Model
30108902
Catalog number
30108902
Device description
Unassayed Testosterone QC Material - 20 mL
Published
2020-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049325014879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049325014879040493250148794049325014879

GMDN Terms#

Term, Definition table
TermDefinition
Free testosterone IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of free testosterone in a clinical specimen.

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
Premarket exempt
true
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
0404932501721417beta-Estradiol Saliva ELISA30121045301210452020-12-29
04049325003545Testosterone Luminescence ImmunoassayRE62031RE620312020-10-20
04049325006546Testosterone Luminescence ImmunoassayRE62039.RE62039.2020-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21