FDA.reportPublic FDA data

Atellica CH Lactate_2 (Lac_2)

Primary DI
00630414287270
Brand
Atellica CH Lactate_2 (Lac_2)
Company
Siemens Healthcare Diagnostics Inc.
Model
11532568
Catalog number
11532568
Device description
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Published
2020-08-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414287270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414287270006304142872706304142872700630414287270

GMDN Terms#

Term, Definition table
TermDefinition
Lactate IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright. Do not freeze.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
1
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414287201Atellica HEMA Calibrator11374312113743122026-02-06
00630414289694Atellica HEMA 580 Analyzer (SMS ready)11315457113154572026-02-06
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80816042014549FORAFORA CARE INC.KHP2025-05-06
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00380740158392ARCHITECTABBOTT IRELANDKHP2024-01-24
00380740158408AlinityABBOTT IRELANDKHP2024-01-24
00816042014505FORAFORA CARE INC.KHP2023-10-31
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2023-08-08
06971674866756BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866763BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866770BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
00630414305066Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
04015630918911Lactate Gen.2Roche Diagnostics GmbHKHP2021-01-18
04015630925148Lactate Gen.2Roche Diagnostics GmbHKHP2021-01-18
04015630926954Lactate Gen.2Roche Diagnostics GmbHKHP2021-01-18
04713648766530THE EDGE Blood Lactate Monitoring SystemAPEX BIOTECHNOLOGY CORP.KHP2021-01-18
04713648766547THE EDGE Blood Lactate Test Strip (non-sterile)APEX BIOTECHNOLOGY CORP.KHP2021-01-18
04713648766554THE EDGE Lactate Control SolutionAPEX BIOTECHNOLOGY CORP.KHP2021-01-18
00054749005505i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00842768005398Dimension® Flex® reagent cartridge LASiemens Healthcare Diagnostics Inc.KHP2020-09-24
00842768015243Dimension Vista® Flex® reagent cartridge LASiemens Healthcare Diagnostics Inc.KHP2020-09-24
03610230007068Yumizen C1200 LactateHORIBA ABX SASKHP2020-09-09
00380740179199AlinityAbbott GmbHKHP2020-08-28
00630414606095epoc NXS HostEpocal IncKHP2020-06-18
10758750004454VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHP2020-04-18
10758750004911VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHP2020-04-18
07613336121351Lactate Gen.2Roche Diagnostics GmbHKHP2020-03-05
05055273204070L-LACTATE (LAC)RANDOX LABORATORIES LIMITEDKHP2019-06-03
05055273204094L-LACTATE (LAC)RANDOX LABORATORIES LIMITEDKHP2019-06-03
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSKHP2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSKHP2018-09-21