FDA.reportPublic FDA data

SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS

Primary DI
00850065007489
Brand
SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Company
HF ACQUISITION CO. LLC
Model
1023770
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032914000MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPSRaven Biological Laboratories, Inc.2004-05-25FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065007489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065007489008500650074898500650074890850065007489

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-331-1984customerservice@healthfirst.com

Regulatory Flags#

DUNS number
045657305
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065007540STAT KIT SM5 EMERGENCY MEDICAL KITSTAT KIT SM5 EMERGENCY MEDICAL KIT10244702026-01-05
00850065007557HSM STAT KIT 550 EMERGENCY MEDICAL KITHSM STAT KIT 550 EMERGENCY MEDICAL KIT10245102026-01-05
00850065007564HSM STAT KIT 550-AI EMERGENCY MEDICAL KITHSM STAT KIT 550-AI EMERGENCY MEDICAL KIT10245502026-01-05
00850065007496SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS10237802025-06-23
00850065007434Criti-Kit 200-AICriti-Kit 200-AI1022670 2024-06-14
00850065007465Criti-Kit Narcan Opioid Overdose Kit – 2 DosesCriti-Kit Narcan Opioid Overdose Kit 10189402024-05-20
00850065007342MOBILE ACLS V2 EMERGENCY MEDICAL KIT100347110034712020-08-17
00850065007267SM ORGANIZERSM ORGANIZER10077612023-12-29
00850065007274STAT KIT SM7 EMERGENCY MEDICAL KITSTAT KIT SM710034912023-12-29
00850065007281STAT KIT SM10 EMERGENCY MEDICAL KITSTAT KIT SM1010035012023-12-29
00850065007298STAT KIT SM27 EMERGENCY MEDICAL KITSTAT KIT SM2710034812023-12-29
00850065007304STAT KIT SM30 EMERGENCY MEDICAL KITSTAT KIT SM3010035112023-12-29
00850065007311STAT KIT 550 EMERGENCY MEDICAL KITSTAT KIT 55010066112023-12-29
00850065007328STAT KIT 550-AI EMERGENCY MEDICAL KITSTAT KIT 550-AI10134012023-12-29
00850065007335STAT KIT 750 EMERGENCY MEDICAL KITSTAT KIT 75010065512023-12-29
00850065007359STAT KIT 750-AI EMERGENCY MEDICAL KITSTAT KIT 750-AI 10065612023-12-29
00850065007397STAT KIT Z-1000 MOBILE ACLS EMERGENCY MEDICAL KITSTAT KIT Z-1000 MOBILE ACLS10221002023-12-29
00850065007403CRITI-KIT 200 EMERGENCY MEDICAL KITCRITI-KIT 200 10035412023-12-29
00850065007410SM7 SELECT EMERGENCY MEDICAL KITSTAT KIT SM7 SELECT10183512023-12-29
00850065007427SM27 SELECT EMERGENCY MEDICAL KITSM27 SELECT10183312023-12-29

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Primary DI, Brand, Company table
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107073878151173M™ Attest™3M COMPANYFRC2026-04-10
107073878151243M™ Attest™3M COMPANYFRC2026-04-10
307073878129123M™ Attest™3M COMPANYFRC2026-04-10
307073878129363M™ Attest™3M COMPANYFRC2026-04-10
307073878129433M™ Attest™3M COMPANYFRC2026-04-10
307073878129503M™ Attest™3M COMPANYFRC2026-04-10
07798375773607BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037071319ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
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07798375773539ProEdgeTERRAGENE S.A.FRC2025-10-16
10686864061257AssureCheck™TERRAGENE S.A.FRC2025-10-16
07798375773034BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
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M9850341001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C1Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T1Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985055100T1Dual Spore Strip - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsMESA LABORATORIES, INC.FRC2024-12-18
07798375772624BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772945BIOTRACE™TERRAGENE S.A.FRC2024-11-12
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