FDA.report

Atellica IM LH

Primary DI
00630414294209
Brand
Atellica IM LH
Company
Siemens Healthcare Diagnostics Inc.
Model
11206256
Catalog number
11206256
Device description
Luteinizing Hormone (LH) - Atellica IM - RGT - 550T
Published
2020-05-31
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
false

Related Records

Contact Domains

Product Codes

CodeName
CEPRADIOIMMUNOASSAY, LUTEINIZING HORMONE

Product Code Classifications

CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414293707PrimaryGS10
00630414294209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293707006304142937076304142937070630414293707
00630414294209006304142942096304142942090630414294209

GMDN Terms

TermDefinition
Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
064608573
Device count
5
DM exempt
false
Premarket exempt
true
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

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00630414289700Atellica HEMA Slidemaker Stainer (SMS)11315459113154592026-02-06
00630414289953Atellica HEMA Diluent11374303113743032026-02-06
00630414289960Atellica HEMA Diluent11374304113743042026-02-06
00630414312460Atellica HEMA Cleaner11374306113743062026-02-06
00630414312477Atellica HEMA HGB11374307113743072026-02-06
00630414290003Atellica HEMA Baso11374308113743082026-02-06
00630414312484Atellica HEMA RET/PLTO11374309113743092026-02-06
00630414312491Atellica HEMA Diff11374310113743102026-02-06
00630414312507Atellica HEMA Decon11374311113743112026-02-06
00630414323640Atellica HEMA Control (L)11374313113743132026-02-06
00630414323657Atellica HEMA Control (N)11374314113743142026-02-06
00630414323534Atellica HEMA Control (H)11374315113743152026-02-06
00630414323541Atellica HEMA Retic Control (L)11374316113743162026-02-06
00630414323558Atellica HEMA Retic Control (N)11374317113743172026-02-06
00630414323565Atellica HEMA Retic Control (H)11374318113743182026-02-06
00630414323572Atellica HEMA Control BF (N)11374319113743192026-02-06
00630414323589Atellica HEMA Control BF (H)11374320113743202026-02-06
00630414323596Atellica HEMA SMS W-G Stain11559862115598622026-02-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336218402Elecsys LHRoche Diagnostics GmbHCEP2026-02-19
00850054026712AccuDiag™ LH ELISADiagnostic Automation, Inc.CEP2026-01-30
00850049545495QMedix™Diagnostic Automation, Inc.CEP2025-12-24
06923304611144Sims ovulation test kitWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2025-12-03
24562185399718CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
04048474012897LH-Serum ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
04048474012903LH-Urine ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
15099590575243Access hLHBeckman Coulter, Inc.CEP2024-04-23
06923304611120FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
06923304611137FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
10050428296643CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
04048474053623LHDRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-09-01
04048474041033LH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-08-31
00840239053626LHDRG International IncCEP2023-08-26
00840239012890LH-Serum ELISADRG International IncCEP2023-08-22
00840239012906LH-Urine ELISADRG International IncCEP2023-08-22
06923304611113INSTANT Aid By PUR-estWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2023-08-15
15099590232276Access hLHBeckman Coulter, Inc.CEP2023-06-26
B261CANLH40400DBC Luteinizing Hormone (LH) ELISADiagnostics Biochem Canada IncCEP2022-11-15
06925912718925iFlash-LHShenzhen YHLO Biotech Co., Ltd.CEP2022-10-26
10036800493916Topcare TOPCO ASSOCIATES, LLCCEP2022-03-07
10041260012461Kroger KROGER CO., THECEP2021-08-04
10041220524546H.E.B H. E. BUTT GROCERY COMPANYCEP2021-06-13
00404847412895LH-Serum ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2021-06-07
00404847412901LH-Urine ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2021-06-07
00404847453621LHDRG Instruments Gesellschaft mit beschränkter HaftungCEP2021-06-07
00840239041036LH ELISADRG International IncCEP2021-06-07
08719699634633iProvenSevenground Trading B.V.CEP2021-03-19
10087701433631Good Neighbor PharmacyAMERISOURCEBERGEN DRUG CORPORATIONCEP2020-11-11
20370797011010Dr. Talbot'sTALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLCCEP2020-10-23