FDA.reportPublic FDA data

Atellica CH Lactate_3

Primary DI
00630414305066
Brand
Atellica CH Lactate_3
Company
Siemens Healthcare Diagnostics Inc.
Model
11537218
Catalog number
11537218
Device description
Lactate_3 (LAC_3) Atellica CH
Published
2023-05-10
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
00630414610979PrimaryGS10
00630414305066Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414610979006304146109796304146109790630414610979
00630414305066006304143050666304143050660630414305066

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
2
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
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24
00630414177038ADVIA Centaur® TSH10309959103099592016-09-24
00630414556093ADVIA Centaur® SHBG Calibrator10285318102853182016-09-24
00630414559704ADVIA Centaur® T3 MCM10361928103619282016-09-24
00630414574516ADVIA® Chemistry Hemoglobin A1c_3 Calibrators10491408104914082016-09-24
00630414579160ADVIA Centaur® iPTH10492369104923692016-09-24
00630414585345ADVIA Centaur® iPTH10493615104936152016-09-24
00630414585352ADVIA Centaur® iPTH10493616104936162016-09-24
00630414587486ADVIA Centaur® iPTH Calibrator10630628106306282016-09-24
00630414587882ADVIA Centaur® Systems VitD Calibrator10630911106309112016-09-24
00630414600611ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents10916067109160672016-09-24
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05700693930978ABL90 FLEXRadiometer Medical ApSKHP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSKHP2026-07-09
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05700699447579SP90Radiometer Medical ApSKHP2026-07-09
05700699461056SC90Radiometer Medical ApSKHP2026-07-09
05700699461087SC90Radiometer Medical ApSKHP2026-07-09
05700699461094SC90Radiometer Medical ApSKHP2026-07-09
05700699461100SC90Radiometer Medical ApSKHP2026-07-09
05700699461605SC90Radiometer Medical ApSKHP2026-07-09
00816042014543FORAFORA CARE INC.KHP2025-05-06
80816042014549FORAFORA CARE INC.KHP2025-05-06
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00630414610979Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480626248Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00630414606460epoc Host2Epocal IncKHP2020-07-15
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.KHP2020-04-15
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSKHP2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSKHP2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSKHP2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSKHP2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSKHP2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSKHP2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSKHP2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSKHP2018-09-21