FDA.reportPublic FDA data

Acetylcholine Receptor Autoantibodies (ARAb) RRA

Primary DI
04049325001404
Brand
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Company
IBL International GmbH
Model
RE21021
Catalog number
RE21021
Device description
Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 100 determinations
Published
2016-09-24
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
NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-BlockingImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049325001404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049325001404040493250014044049325001404

GMDN Terms#

Term, Definition table
TermDefinition
Acetylcholine receptor antibody IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to acetylcholine receptor in a clinical specimen, using a radioimmunoassay method. It is typically used in the differential diagnosis of Myasthenia gravis (MG).

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
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
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
06932503580984Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-05
06932503581035Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-05
06932503581097Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-05
06932503581325Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-05
06932503580861Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580878Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580885Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580892Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580908Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580915Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580922Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580939Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580946Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580953Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580960Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580977Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503580991Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581004Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581011Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581028Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581042Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581059Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581066Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581073Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581080Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581103Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581110Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581127Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581134Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04
06932503581141Tracheal Stent system (OTW)Micro-Tech (Nanjing) Co., Ltd.NST2023-06-04